Predicate Devices

K933613, K030051, K974703, K023293, K950866, K935300, K926187

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies focus solely on physical immobilization systems and materials, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No.
The device's intended use is for fixation and repositioning of patients during radiotherapy and diagnostics, which are support functions for a therapeutic procedure (radiotherapy) or a diagnostic procedure, but the device itself does not directly treat or diagnose a disease.

Diagnostic

No

The devices described are immobilization systems and cushions used to position and fix patients during radiotherapy and diagnostics. They do not themselves perform diagnostic functions; rather, they support the patient during diagnostic procedures performed by other equipment.

SaMD (Software as a Medical Device)

No

The device description explicitly lists several types of physical immobilization systems and cushions made of materials like polystyrene beads and thermoplastic, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is focused on the physical positioning and immobilization of patients during radiotherapy and diagnostics. This is a physical process performed on the patient's body.
Device Description: The device description details physical systems and materials used for positioning and fixation (baseplates, cushions, masks, etc.). These are external devices applied to the patient.
Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or diagnostic testing of samples.

The device described is a medical device used for patient support and positioning during medical procedures, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. 1
Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. 2
Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. 3
Positioning of the lower abdomen of a patient during radiotherapy and diagnostics. 4
Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics. 5
Fixation and (re)positioning of the patient during radiotherapy and diagnostics. 6
Fixation and (re)positioning of the patient during radiotherapy and diegnostics. 7

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Head and neck area, lung and thorax area, lower abdomen, hip and lower extremities.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K933613, K030051, K974703, K023293, K950866, K935300, K926187

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

K060737

MAR 3 1 2006

510(k) summary, IYE- positioning devices

Image /page/0/Picture/3 description: The image shows the word "Sinmed" in bold, black letters. Below the word "Sinmed" are the words "Radiotherapy products" in a smaller font. The word "Sinmed" appears to be a company name or brand, and the words "Radiotherapy products" indicate the type of products the company offers.

Sinmed head and shoulder positioning and immobilization systems. (Baseplates)

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	-Posifix 1,2,4,5,7 head and neck systems
-Positilt head inclination system
-Posifix Pediatric
-Headsupports
-Blocks and wedges
-Shouldersupport cushion
Common name:	Head and shoulders immobilization systems.
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	Fixation and (re)positioning of the head- and neck during radiotherapy and
diagnostics.
Substantial Equivalence Device:	The Sinmed head and neck immobilization systems are defined as
Substantially Equivalent (SE) to the Bionix 3-Way Head immobilizator; 3Way
DeLuxe Reusable Frame, manufactured by Bionix Development corporation.
Registration number: 1526854) and cleared by FDA with K933613
Description of the devices: See Sinmed
product Catalogue 2006	Page: 4
8
4
9
12
13	Product:
-Posifix 1,2,4,5,7 head and neck systems
-Positilt head inclination system
-Posifix Pediatric
-Headsupports
-Blocks and wedges
-Shouldersupport cushion
Summary of the technological
characteristics of your device
compared to the predicate device	The Sinmed devices indicated above are all designed to position the head-
and neck of a patient for diagnostics and radiotherapy and exactly reposition
it several times. All these products can be used in combination with each
other to optimize the set-up of a patient. This is exactly the purpose of the
Bionix 3-Way Head Immobilizator. The same kind of construction and
materials are used to reach this. Products from both companies are used for
the same kind of radiotherapy treatments. These products from both

companies are really competitive systems

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Radiotherapy products

	Sinmed head and neck immobilization baseplates	Bionix 3-WAY HEAD IMMOBILIZER
Intended use	Fixation and (re)positioning of the head- and neck during radiotherapy and diagnostics	Fixation and (re)positioning of the head and neck during radiotherapy and diagnostics
Target population.	Radiotherapy patients with tumors in head- and neck area.	Radiotherapy patients with tumors in head- and neck area.
Position of the patient	Lying on a couch in prone or supine position.
Shoulders and head are positioned by in a certain position using accessories for an optimized treatment.	When you're treating tumors in the head and neck region, accurate, reproducible positioning is essential. Our 3-Way Immobilizer works on prone, supine and lateral positioned patients.
Material	Carbon fiber and acrylic, polyethylene foam.
The skin contact materials carbon fiber and acrylic are exactly the same as those used in the predicate device. The cytotoxicity test of the carbon fiber top layer we use is enclosed in Chapter 11.
The PE-Foam material is commonly used in radiotherapy, the toxicity report is enclosed in Chapter 11.	Carbon fiber and acrylic version baseplates
Dimensions	Square shaped baseplate which follows the patients contours of head (Posifix -4, -5, -7, Positilt) or head and shoulders (Posifix-1 and - 2 and - Pediatric).	Square shaped baseplate which follows the patients contours of the head.
Design / Shape	Flat baseplate on which the thermoplastic mask and various headsupports can be placed.
Using the Positilt or other accessories, the baseplate can be inclined to change the position of the head.	Flat baseplate on which the thermoplastic mask and various headsupports can be placed. The baseplate can be inclined to change the position of the head.
Possible adjustments	Head can be lifted or inclined by using the blocks and wedges or the Positilt system.	Head can be tilted or inclined by using the 3-way head immobilizator.
Couchfixation	The Aluminium fixationrails connects the baseplate to the couch.
The adjustable aluminium rails can be mounted on all of our baseplates. They allow the baseplate to be locked down in the desired position on the simulator or treatment couch.
Depending on the type of couch, one can choose from several mounting brackets.	The SecureFit bar connects the baseplate to the couch. Our SecureFit bar was designed to index our immobilization devices to the Exact™ Couch for increased accuracy.
Accessories	Foam headsupports, blocks and wedges, which can position the head for an optimized treatment. Foam Shouldersupport cushion for a better and more comfortable positioning of the patient.
Thermoplastic mask-material which can be placed on the baseplate with plastic profiles.	Headsupports designed for a dedicated treatment can be used on these baseplates.
Foam blocks and wedges can be used for a better and more comfortable positioning of the patient.
Thermoplastic mask-material which can be placed on the baseplate with plastic profiles.
Compatibility with the environment and other devices	Can be used on all brands of couches in diagnostic and radiotherapy environment.	Can be used on an Exact™ couch in diagnostic and radiotherapy environment.

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

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Sinmed head and shoulders immobilization systems. (Extensionplates)

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	-Posifix-EXT systems
-Shoulderretractor
-Couchtop Cover
Common name:	Head and shoulders immobilization systems
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	Fixation and (re)positioning of the head- and neck during radiotherapy and
diagnostics.
Substantial Equivalence Device:	The Sinmed head and neck immobilization systems are defined as
Substantially Equivalent (SE) to the Bionix, Versaboard, Model 7040,
manufactured by Bionix Development Corporation, Registration number:

and cleared by FDA with K030051 | |
| Description of the devices: See Sinmed
product Catalogue 2006 | Page:
8
35
5 | Product:
Posifix-EXT systems
Shoulderretractor
Couchtop Cover |
| Summary of the technological
characteristics of your device compared
to the predicate device | The Sinmed Posifix-EXT system, in combination with the Shoulderretractor
and the Couchtopcover, can exactly be compared with the Bionix
Versaboard. These products from both companies are intended to position
the head- and neck of the patient outside the couch, to optimize the
treatment possibilities. The Bionix baseplate is longer and also supports
the back and buttocks of the patient. Sinmed has chosen to design a
shorter version, and creates this total support by using the couchtop cover.
On both systems the mask-material can be placed as well as a choice of
headsupports for the positioning of the head.
In order to further increase the space around the head of the patient, the
shoulders should be suppressed. Sinmed uses a separate Shoulder
retractor for this, and Bionix uses the relocatable shoulder suppression
system which can be integrated in the baseplate.
Both systems are placed and locked on the cranial side of the radiotherapy
treatment couch. Both systems are specially developed for use during
radiotherapy treatment, and not during diagnostics. | |

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Radiotherapy products

	Sinmed head and neck immobilization	Bionix
	baseplates (Extensionplate)	VERSABOARD, MODEL 7040

Intended use	Fixation and (re)positioning of the head- and
neck during radiotherapy, especially IMRT-
treatment.	Fixation and (re)positioning of the head- and neck
during diagnostics and radiotherapy.
This new board is ideal for IMRT and will solve many of
your hard to reach angles and maximize your treatment
angles.
Target population.	Patient with tumors in head- and neck-area,
treated with IMRT-techniques	Patient with tumors in head- and neck-area, treated with
IMRT-techniques
Special feature in
relation to head and
shoulder immob.
systems.(baseplates)	These extension plates position the head- and
shoulders of the patient outside the couch,
which enlarges the radiotherapy treatment
possibilities.	It extends off the couch for a broad range of treatment
options while improving therapy accuracy.
Position of the
patient	Shoulderretractor suppresses the shoulders for
an optimized treatment.	The optional relocatable shoulder suppression system
allows you to comfortably push down the shoulders for
better reproducibility.
Material	Carbon fiber sandwich construction, PE-foam.
The skin contact materials carbon fiber is
exactly the same as that used in the predicate
device. The cytotoxicity test of the carbon fiber
top layer we use is enclosed in Chapter 11.
The PE-Foam material is commonly used in
radiotherapy, the toxicity report is enclosed in
Chapter 11.	Carbon fiber sandwich construction..
Dimensions	Baseplate supports the head and shoulders of
the patient. When also using the couchtop
cover, the patient support is completely flat
from head to buttocks.	Baseplate supports the patient from head to buttocks.
Design / Shape	Head- and shoulders are supported by the
baseplate and positioned outside the couch.	Head and shoulders are supported by the baseplate. It
extends off the couch for a broad range of treatment
options while improving therapy accuracy.
Possible
adjustments	No adjustments possible with the baseplate.
Adjustments in positioning of the head- and
shoulders can be done by using accessories
like different headsupports or the
shoulderretractor.	No adjustments possible with the baseplate.
Adjustments in positioning of the head- and shoulders
can be done by using accessories like different
headsupports or the shoulder suppression system.
Couchfixation	Flat baseplate which hooks onto the cranial
side of the treatment couch and can be locked.
After mounting onto the couch, the construction
is fixed with a locking mechanism.	Baseplate can be placed on the couch and attached
onto the cranial side.
Accessories	-Thermoplastic mask-material which can be
placed on the baseplate with fixation profiles.
-Various headsupports designed for a
dedicated treatment can be used on this
baseplate.
-Couchtop Cover to overcome the height
difference when also using other baseplates.	-Thermoplastic mask-material which can be placed on
the baseplate with plastic profiles.

Headsupports designed for a dedicated treatment can
be used on this baseplate. |
| Compatibility with
the environment and
other devices | Three types of which each can be placed on a
Varian, Siemens or Elekta couch. | Can be placed on a Varian couch |

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

2-16

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Image /page/4/Picture/1 description: The image shows the word "Sinmed" in a bold, sans-serif font. Below the word "Sinmed" is the phrase "Radiotherapy products" in a smaller, regular font. The word "Sinmed" appears to be the name of a company or brand, and the phrase "Radiotherapy products" indicates the type of products that the company offers.

Sinmed lung and thorax immobilization systems

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	-Thorawedge
-Posirest
-Posiboard
-PET-armsupport
Common name:	Lung and thorax immobilization systems
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	Positioning the patient for irradiation in the lung- and thorax area.
Substantial Equivalence Device:	The Sinmed Lung and thorax immobilization systems are defined as
Substantially Equivalent (SE) to the MedTec CARBON FIBER BREAST
BOARD, manufactured by MED-TEC,INC. (Registration number:

and cleared by FDA with K974703. | | | | | | | | | | |
| Description of the devices: See Sinmed
product Catalogue 2006 | Page: Product: 27 Thorawedge 26 Posirest 23 Posiboard 29 PET-armsupport | | | | | | | | | | |
| Summary of the technological
characteristics of your device compared
to the predicate device | The Medtec Breastboard is a device intended to position patients
undergoing irradiation treatment in the breast- and lung area. This is
exactly the same purpose of the Sinmed devices in this group.
The patient support of the Medtec Breastboard can be inclined for better
treatment. This same inclination of the upper body is also possible with the
Sinmed Posiboard and the Thorawedge.
To keep the arms out of the treatment area, arms above the head, various
armsupports can fixed on the Medtec Breastboard. This fixation of
armsupports is also possible on the Sinmed Posiboard. This positioning of
the arms above the head to achieve more space around the breast and
lung-area is also the exact intended use of the Sinmed Posirest and PET-
armsupport and the Thorawedge system.
The features of the Medtec Breastboard can all be found in the Sinmed
Posiboard. The other three Sinmed lung and thorax immobilization
systems are less complicated devices with the same purpose, each with | | | | | | | | | | |

.

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Radiotherapy products

| | Sinmed Lung and thorax | MedTec
Carbon Fiber Breast Board |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | immobilization systems | |
| Intended use | Positioning the patient for irradiation in the
lung- and thorax area. | Positioning the patient for irradiation in the lung-
and thorax area. |
| Target
population. | Patients with tumors in breast and thorax. | Patients with tumors in breast and thorax |
| Position of the
patient | Supine position, can be inclined, with arms
positioned above the head | Supine position, can be inclined, with arms
positioned above the head |
| Material | Carbon fiber sandwich construction, PE-
Foam, and acrylic. Only non-metal
materials are used, like foam, acrylic and
carbon fiber sandwich in the treatment
area.
The skin contact material carbon fiber is
exactly the same as that used in the
predicate device. The cytotoxicity test of
the carbon fiber top layer we use is
enclosed in Chapter 11.
The PE-Foam material is commonly used
in radiotherapy, the toxicity report is
enclosed in Chapter 11.
The acrylic material is the same used in the
Sinmed head and shoulder positioning and
immobilization systems. (baseplates) and
is identical to the material used in the
predicate device Bionix 3-WAY HEAD
IMMOBILIZER. | Carbon-fiber sandwich, there are no metal
components in the vital scanning and treatment
areas making it even more "CT-friendly"; |
| Dimensions | Optimized dimensions (width) to be CT-
scanner compatible | Available in both standard and CT-compatible
widths. |
| Design / Shape | Baseplate, with an aperture for placing
various headsupports, Above the head the
arms can be placed by using various
armsupports. | Baseplate, with an aperture for placing various
headsupports, Above the head the arms can be
placed by using various armsupports. |
| Possible
adjustments | 0-25 degrees inclination possible with
Posiboard and Thorawedge.
0 degrees inclination with Posirest and
PET-armsupport. | 0-25 degrees inclination possible. |
| Couchfixation | Posirest, Posiboard, PET-armsupport is
fixed onto the couch with fixationstrips. | The Medtec Carbon Fiber Breastboard is fixed onto
the couch using the MedTec fixation rails. |
| Accessories | Various headsupports for a comfortable
patient positioning. Various armsupports
for patient positioning. | Various headsupports for a comfortable patient
positioning. Various armsupports for patient
positioning. |
| Compatibility
with the
environment
and other
devices | Due to the chosen construction and
materials, these products can be used
during both diagnostics and radiotherapy. | Due to the chosen construction and materials,
these products can be used during both
diagnostics and radiotherapy. |

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

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Sinmed pelvis and lower extremities immobilization systems (Bellyboard system)

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	Bellyboard
Prone thorax support cushion for Bellyboard
Common name:	Pelvis and lower extremities immobilization systems (Bellyboard system)
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	The Sinmed Bellyboard has been developed in order to reduce the
irradiated small bowel volume of gynaecological patients undergoing
treatment in the pelvic region.
Substantial Equivalence Device:	The Sinmed Pelvis and lower extremities immobilization systems
(Bellyboard) are defined as Substantially Equivalent (SE) to the MedTec
Bellyboard, manufactured by MedTec. INC.
(Registration number: 1932738) and cleared by FDA with K023293.
Description of the devices: See Sinmed
product Catalogue 2006	Page: 31
Product: Bellyboard
Page: 32
Prone thorax support for Bellyboard
Summary of the technological
characteristics of your device compared
to the predicate device	The Sinmed Bellyboard is substantially equivalent to the MedTec
Advanced Belly board System in design, construction, and function. The
Sinmed BellyBoard is flat and has a similar, generally rounded
rectangular-shaped contour, with areas specifically designed for the
head, abdomen, and thighs. The Prone Thorax support cushion has a
contoured opening so that the patient may rest his/her head comfortably
in the prone position during the treatment process. The abdominal
cushion is also designed with an open, contoured cut out region. The
patient is positioned over the abdominal cushion such that the belly drops
into the cut out region during the radiation therapy session. The Sinmed
BellyBoard is constructed in a manner similar to the Advanced Belly
board System from Med-Tec. having a hollow thermoformed

thermoplastic shell.

7

Sinmed

Radiotherapy products

	Sinmed Bellyboard system	MedTec Bellyboard
Intended use	The Sinmed Bellyboard has been
developed in order to reduce the
irradiated small bowel volume of
gynaecological patients undergoing
treatment in the pelvic region.	The Intermediate Bellyboard features a standard-
sized portal for displacement of the small bowel of
gynecological patients.
Target population	Patients with tumors in the lower-
abdomen area	Patients with tumors in the lower-abdomen area
Position of the
patient	Prone position on this device	Prone position on this device
Material	Carbon fiber sandwich shell construction
The skin contact materials carbon fiber is
exactly the same as that used in the
earlier described predicate device: Bionix
VERSABOARD, MODEL 7040. The
cytotoxicity test of the carbon fiber top
layer we use is enclosed in Chapter 11.
PE-Foam: The PE-Foam material is
commonly used in radiotherapy, the
toxicity report is enclosed in Chapter 11.	Thermoformed plastic shell with a foam core
Dimensions	Thick hollow construction with an
aperture to place the belly. Flat top-part
for positioning the arms and head.	Thick hollow construction with an aperture to place
the belly. Flat top-part for positioning the arms and
head.
Design / Shape	Ergonomic design for a comfortable
position of the patient. Extra ruler for
laser-alignment along the sides of the
Bellyboard.	It features ergonomically correct contours for
patient comfort and support, along with millimeter
scales for laser alignment.
Possible
adjustments	No adjustments possible, only by using
additional cushions like the prone-
cushion.	"Interchangeable belly inserts make this Bellyboard
system highly versatile and patient- and setup-
friendly."
Couchfixation	Can be placed at indexed positions on
the couch, using fixation strips.	Indexed Patient Positioning System-compatible,
using the MedTec rails
Accessories	Prone cushion for Bellyboard to improve
the position on the Bellyboard	Various cushions to optimize the positioning and
comfort of the patient
Compatibility with
the environment
and other devices	This device can be used both in
combination with a CT-scanner and an
accelerator.	This device can be used both in combination with a
CT-scanner and an accelerator.

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

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Image /page/8/Picture/1 description: The image shows the logo for Sinmed Radiotherapy products. The logo consists of the word "Sinmed" in a bold, sans-serif font, with the "S" stylized to look like a bracket. Below the word "Sinmed" are the words "Radiotherapy products" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to promote Sinmed's products and services in the field of radiotherapy.

Sinmed Pelvis and lower extremities immobilization systems

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	-Posifix-12
-Multifix
-Combifix-system (Baseplate with Kneefix and Feetfix)
-Multi Purpose Support cushions
Common name:	Pelvis and lower extremities immobilization systems
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	Positioning of hip and lower extremities of a patient for radiotherapy.
Substantial Equivalence Device:	The Sinmed Pelvis and lower extremities immobilization systems depicted above are defined as Substantially Equivalent (SE) to the Hip Fixation System manufactured by MedTec, INC.
(Registration number: 1932738) and cleared by FDA with K950866.
Description of the devices: See Sinmed product Catalogue 2006	Page: Product:
36 Posifix-12
36 Multifix
35 Combifix-system (Baseplate with Kneefix and Feetfix)
53 Multi Purpose Support cushions
Summary of the technological characteristics of your device compared to the predicate device	All four products: Posifix-12, Multifix, Combifix-system (Baseplate with Kneefix and Feetfix) and the Multi Purpose Support cushions are products for positioning and immobilization of pelvis and lower extremities. These Sinmed products can be used individually or in combination with each other. The Posifix-12 and the Multifix are baseplates which should be used in combination with thermoplastic masks to fix the pelvis and lower extremities properly. The Medtec Hip Fixation system also uses the thermoplastic masks to fix the hips and extremities of the patient. The Sinmed Combifix is a system with which the pelvis and lower extremities are positioned in the same way as with the Medtec HipFix, but cannot be

fixed with Posicast masks. The Sinmed Multi Purpose Support Cushions are actually important accessories of the Sinmed Multifix. With these cushions, the positioning of the extremities can be optimized and fixed with the thermoplastic mask-material.

Sinmed Premarket Notification Submission 510(k)

9

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

	Sinmed Pelvis and lower extremities	MedTec
	immobilization systems	Hip Fixation System

Intended use	Positioning of hip and lower extremities of a
patient for radiotherapy.	The HipFix system is a popular choice for hip and
pelvis immobilization in either the prone or supine
position.
Target
population.	Patients undergoing irradiation treatment in
pelvis or lower extremities.	Patients undergoing irradiation treatment in pelvis
or lower extremities.
Position of the	Supine position (Combifix)	Prone or supine position.
patient	Or
Prone and supine position. (Posifix-12,
	Multifix and MultiPurpose Support cushions)
Material	Carbon fiber sandwich or plastic (acrylic and
PE-Foam) devices.
The skin contact materials carbon fiber is
exactly the same as that used in the earlier
described predicate device: Bionix
VERSABOARD, MODEL 7040. The
cytotoxicity test of the carbon fiber top layer	Carbon fiber with plastic
	we use is enclosed in Chapter 11.
PE-Foam: The PE-Foam material is
commonly used in radiotherapy, the toxicity
report is enclosed in Chapter 11.
The acrylic material is the same used in the
Sinmed head and shoulder positioning and
immobilization systems. (baseplates) and is
identical to the material used in the
	predicate device Bionix 3-WAY HEAD
IMMOBILIZER.
Design	Baseplate on which the hip and lower
extremities of the patient can be positioned
by using an individually shaped mask, or
using a Kneefix- or Feetfix or a Multi
Purpose Support Cushion.	Baseplate on which the hip and lower extremities of
the patient can be positioned by using an
individually shaped mask. Various cushions can be
used to improve the patient positioning.
Possible	These devices can be adjusted to optimize	These devices can be adjusted to optimize the fit
adjustments	the fit for the patient. Individual adjustment	for the patient. Individual adjustment can be
reached by changing distances or using individual
	can be reached by changing distances or
using Posicast masks.	masks.
Couchfixation	Baseplates can be positioned on the couch
on indexed positions.	Indexed Patient Positioning System-compatible
Accessories	Repovac vacuum cushions
Thermoplastic Posicast mask material
Multi Purpose Support Cushion.	Vac-Lok™ vacuum cushions
Thermoplastic mask material
Compatibility
with the
environment and
other devices	The -Posifix-12, Multifix, Combifix-system
and Multi Purpose Support cushions can be
used both in the diagnostic and treatment
environment, due to the materials and
construction chosen.	The Hip Fixation System can be used both in the
diagnostic and treatment environment, due to the
materials and construction chosen.

Brief discussion of the
nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No substantial equivations are performed, but from clinical experience is known that both products function in the same way.

.

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Image /page/10/Picture/1 description: The image shows the word "Sinmed" in a bold, sans-serif font. The "S" in "Sinmed" is stylized with a curved line above it. Below the word "Sinmed", the words "Radiotherapy products" are written in a smaller, sans-serif font. There is a line separating the two phrases.

Sinmed Repovac Cushions

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	Repovac cushions
Common name:	Repovac cushions
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	Repovac vacuum cushions provide a comfortable, accurate and
reproducible patient position throughout the total course of a radiation
therapy treatment.
Substantial Equivalence Device:	The Sinmed Repovac cushions depicted above are defined as
Substantially Equivalent (SE) to the Vac-Loc immobilization system
manufactured by Med-Tec INC. (Registration number: 1932738) and
cleared by FDA with K935300.
Description of the devices: See Sinmed
product Catalogue 2006	Page: 45
Product: Repovac cushions
Summary of the technological
characteristics of your device compared to
the predicate device	Sinmed Repovac cushions, are plastic bags, filled with polystyrene
beads and can be made vacuum to follow and keep the contour of a
patient. This vacuumbag can be used during the total treatment to
achieve an identical patient set-up every time.
This is exactly the intended use and functioning of the MedTec vacuum
cushions. Differences can be found in shape, color and top layer

material.

:

11

Sinmed

Radiotherapy products

| | Sinmed Repovac cushions | MedTec
Vac-Lok Immobilization System |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Repovac vacuum cushions provide a
comfortable, accurate and reproducible
patient position throughout the total course of
a radiation therapy treatment. | When a complete vacuum is drawn through the
quick-release valve, the cushion becomes a rigid
and comfortable mold, offering accurate
reproducibility throughout the course of simulation
and treatment. |
| Target
population. | Radiotherapy patients, all kinds of treatments | Radiotherapy patients, all kinds of treatments |
| Position of the
patient | The cushion forms a rigid mould of the patient
by a vacuum that is drawn following the
patient's contours. The quick-release valve
and the airtight polyurethane bag allow the
mould to maintain its shape over a long
period of time. This ensures a reproducible
patient sel-up through imaging, simulation
and treatment of the patient. | While semi-deflated, the cushion is easily molded
around a patient's anatomical contours. When a
complete vacuum is drawn through the quick-
release valve, the cushion becomes a rigid and
comfortable mould, offering accurate
reproducibility throughout the course of simulation
and treatment. |
| Material | Polyurethane sheets with Polystyrene
micropellets. The skin contact materials are
exactly the same as those used in the
predicate device. | A rugged clear urethane and an extra-durable
nylon-reinforced blue urethane material that
resists punctures. Rugged, radiotranslucent
cushions are filled with tiny polystyrene beads. |
| Dimensions | Different dimensions available, square or a
special shape for a special purpose. | Different dimensions available, square or a
special shape for a special purpose. |
| Design / Shape | Various dimensions and shapes available for
various purposes. | Various dimensions and shapes available for
various purposes. |
| Possible
adjustments | Cushion follows the individual contours of the
patients. | Cushion follows the individual contours of the
patients. |
| Couchfixation
Accessories | Cushions cannot be fixed onto the couch.
Vacuum pump, both manual and electrical
"Moulding guides" to facilitate moulding of the
cushion | Cushions cannot be fixed onto the couch.
Electrical Vacuum pump
"Helping hands" to facilitate moulding of the
cushion |
| Compatibility
with the
environment
and other
devices | Some Vacuumcushions are specially
designed for use on Sinmed positioning
devices to improve the positioning and
comfort of the patient. | Some Vacuumcushions are specially designed for
use on Medtec positioning devices to improve the
comfort and positioning of the patient. |

Brief discussion of the nonclinical tests submitted

The Sinmed described devices above are competitive devices to the device to which substantial equivalence is claimed. Both are designed and used for the same purpose. No comparative investigations are performed, but from clinical experience is known that both products function in the same way.

12

Image /page/12/Picture/1 description: The image shows the word "Sinmed" in bold, black letters. Below the word is the phrase "Radiotherapy products" in a smaller, lighter font. The word "Sinmed" is the main focus of the image, with the phrase below providing context about the company or product.

Sinmed Posicast immobilization systems

Date prepared	23-09-05
Submitter	Sinmed BV
Address:	Pasteurstraat 6
2811 DX Reeuwijk
Phone: 0031-182-394495
Fax: 0031-182-395014
Contact person:	Caroline de Keijzer (Quality Manager)
Leo de Mooy (Technical Director)
Tradename:	Posicast
Common name:	Posicast immobilization systems
Classification name:	Linear medical accelerator
Classification:	Class 2 devices, 892.5050 IYE
Intended use:	Immobilization of a patient by using a thermoplastic mask.
Substantial Equivalence Device:	The Sinmed POSICAST IMMOBILIZATION SYSTEM depicted above is defined as
Substantially Equivalent (SE) to the Posicast Immobilization SYSTEM registered by
Huestis Machine Corporation.
(Registration number: 1219183) and cleared by FDA with K926187. The following table
compares the Sinmed POSICAST IMMOBILIZATION SYSTEM and the predicate device.

Huestis has registered this product when they were our representative in 1992. The
distribution of Sinmed Posicast will be through another American company. Therefore we
want to register this product under our own name. So the product we want to register is
exactly the same as the material Huestis has registered in 1992. |
| Description of the devices: See Sinmed product Catalogue 2006 | Page: 14-21 Product: Posicast |
| Summary of the technological | The 510(k) for Posicast has been approved by the FDA in 1994 (K926187). The material, |

characteristics of your device compared to the predicate device

intended use etc. have not changed since then. Therefore a comparison seems to be not necessary.

	Sinmed POSICAST IMMOBILIZATION SYSTEM	Huestis Posicast Immobilization SYSTEM
Intended use	Exactly the same	Exactly the same
Target population.	"	"
Position of the
patient	"	"
Material
Dimensions
Design / Shape
Possible
adjustments	"	"
Couchfixation	"	"
Accessories
Compatibility with
the environment
and other devices	"	"

Brief discussion of the nonclinical tests submitted

Both the Sinmed Posicast immobilization system and the Huestis Posicast Immobilization SYSTEM are exactly the same. Therefore no clinical comparative tests are necessary.

Sinmed Premarket Notification Submission 510(k)

13

Image /page/13/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized symbol in the center. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. The symbol in the center appears to be a stylized representation of a human figure or a bird, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2006

Sinmed Holding Internation B.V. % Ms. Patricia L. Murphy Eastern Regional Manager, Medical Certification KEMA Quality B.V. US Medical Operations 4377 County Line Road CHALFONT PA 18914

Re: K060737

Trade/Device Name: Sinmed Immobilization Systems (Head and Shoulder, Lung and Thorax, Pelvis and Lower Extremities, and Posicast) and Sinmed Repovac Cushions Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 16, 2006 Received: March 20, 2006

Dear Ms. Murphy:

We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA `s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (08) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

14

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely vours.

Nancy C. Brigdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

15

Indications for Use

510(k) Number (if known): -

K060737

Device Name:

·Posifix 1,2,4,5,7 -head and neck systems 1 -Posititt head inclination system -Posifix Pediatric
- Headsupports
- -Blocks and wedges
- Shouldersupport cushion
- -Posifix-EXT systems
2 -Shoulderretractor
- -Couchtop cover
ਤੇ -Thorawedge
- -Posirest
- -Posiboard
- ·PET-armsupport
-Bellyboard प
- -Prone thorax support cushion for Bellyboard

5 -Posifix-12 -Multifix -Combifix-system (Baseplate with Kneefix and Feetfix) -Multi Purpose Support cushion -Reporac cushions

હ 7 -Posicast

Indications For Use:

roution and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. 1
Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. 2
Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. 3
Positioning of the lower abdomen of a patient during radiotherapy and diagnostics. 4
Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics. 5
Fixation and (re)positioning of the patient during radiotherapy and diagnostics. 6
Fixation and (re)positioning of the patient during radiotherapy and diegnostics. 7

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

510(k) Sinmed (8030455) IYE-Positioning devices

Nancy C Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060737