Predicate Devices

K091869, K951589, K914752, K912332, K933725

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes electrosurgical and endoscopic instruments with mechanical and electrical functions, but there is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is described as an "electrosurgical device" and its intended use includes "cutting, coagulating, dissection, and manipulation of tissue" during surgical procedures, which are therapeutic actions.

Diagnostic

No

Explanation: The device is described as an electrosurgical device and endoscopic instrument used for cutting, coagulating, dissecting, and manipulating tissue during surgical procedures. There is no mention of it being used for diagnostic purposes (e.g., imaging, measuring, or analyzing to identify a disease).

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical, single-use endoscopic instruments with mechanical and electrical components, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
Device Intended Use: The provided text clearly states the intended use of the Flex™ instruments is for endoscopic surgical procedures to facilitate cutting, coagulating, dissection, manipulation, and housing/introducing a laser fiber directly on tissue within the body.
No Specimen Analysis: There is no mention of analyzing samples taken from the body. The devices are used for direct intervention during surgery.

Therefore, based on the provided information, the Flex™ instruments are surgical devices used in vivo (within the living body), not in vitro (in a test tube or laboratory setting).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.

The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.

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

GCJ, GEI, GEX

Device Description

The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue. The seven instruments are identified as follows:

FlexTM Endoscopic Instruments
Name: FlexTM Monopolar Maryland Dissector, Catalog/REF #: FXG0350D, Monopolar Electrosurgical Yes or No: Yes
Name: FlexTM Monopolar Needle Knife, Catalog/REF #: FXK0350M, Monopolar Electrosurgical Yes or No: Yes
Name: FlexTM Monopolar Spatula, Catalog/REF #: FXE0350M, Monopolar Electrosurgical Yes or No: Yes
Name: FlexTM Needle Driver, Catalog/REF #: FXN0350S, Monopolar Electrosurgical Yes or No: No
Name: FlexTM Fenestrated Grasper, Catalog/REF #: FXG0350F, Monopolar Electrosurgical Yes or No: No
Name: FlexTM Monopolar Scissor, Catalog/REF #: FXS0350M, Monopolar Electrosurgical Yes or No: Yes
Name: FlexTM Laser Fiber Holder, Catalog/REF #: FXL0350U, Monopolar Electrosurgical Yes or No: No

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Bench testing of the Flex™ Monopolar instruments was performed to evaluate device function and durability. Mechanical testing and simulated use testing was conducted to confirm that the device has the necessary mechanical performance for its intended use.

Dimensional verification was performed to confirm that the device dimensions are as specified.

Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with:
IEC 60601-1: 2005 3d Edition: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests.
IEC 60601-2-2:2009. 5th Edition, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

Biocompatibility testing was conducted according to the following ISO Standards:
ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-10:2002 (A1 :2006), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use.

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.

K091869, K951589, K914752, K912332, K933725

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

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Summary

0

JUN 1 1 2014 K140662 Page 1 of 7

510(K) SUMMARY

Submitter Information

Submitter's Name:	Design Standards Corporation
Address:	957 Claremont Road
Charlestown, New Hampshire, 03603
Telephone:	603-826-7744
Fax:	603-826-4406933
Contact Person:	Michele Lucey
Telephone:	603-748-1374
Date Prepared:	May 19, 2014
Device Trade Name:	Flex™ Endoscopic Instruments
Classification:	Class 2
Product Code(s):	GCJ, GEI, GEX
Regulation Number(s):	21 CFR 876.1500 Endoscope and Accessories
Predicate Device:	Covidien SILS™ and Endoscopic Hand Instruments
(K091869, K951589, K914752)
	Microsurge, Inc. Endoscopic Laser Fiber Holder
(K912332)
	United States Surgical Corporation, Endoscopic Needle
Driver (K933725)

Intended Use:

The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

1

The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.

The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.

Device Description/Technological Characteristics:

The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue. The seven instruments are identified as follows

	FlexTM Endoscopic Instruments
Name	Catalog/REF #	Monopolar Electrosurgical
Yes or No
FlexTM Monopolar Maryland
Dissector	FXG0350D	Yes
FlexTM Monopolar Needle Knife	FXK0350M	Yes
FlexTM Monopolar Spatula	FXE0350M	Yes
FlexTM Needle Driver	FXN0350S	No
FlexTM Fenestrated Grasper	FXG0350F	No
FlexTM Monopolar Scissor	FXS0350M	Yes
FlexTM Laser Fiber Holder	FXL0350U	No

Performance Data:

Bench testing of the Flex™ Monopolar instruments was performed to evaluate device function and durability. Mechanical testing and simulated use testing was conducted to confirm that the device has the necessary mechanical performance for its intended use.

Dimensional verification was performed to confirm that the device dimensions are as specified.

Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with:

2

IEC 60601-1: 2005 3d Edition: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests.

IEC 60601-2-2:2009. 5th Edition, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

Biocompatibility testing was conducted according to the following ISO Standards:

ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process

ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity.

ISISO 10993-10:2002 (A1 :2006), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use.

Substantial Equivalence:

Flex™ Endoscopic Surgical Instruments and the predicate devices identified above have the same intended use and similar indications, technological characteristics, and principals of operation. A comparison chart is provided to illustrate substantial equivalence.

Substantial Equivalence Comparison Chart
Feature/
Specification	Flex™
Instruments	Covidien SILS
and
Endoscopic	Microsurge
Laser Fiber
Holder	United States
Surgical
Corporation	Comparison
		Instruments		Endoscopic
Needle
· Driver
Regulatory
Clearance/
Approval
Reference	NA	K091869,
K951589,
K914752	K912332	933725	NA
Product Code	GCJ, GEI	GCJ, GEI	GEX	GCJ	Same
Regulation
Number	21 CFR
876.1500	21 CFR
876.1500	21 CFR
876.4810	21 CFR
876.1500	Same
Regulation
Name	Endoscope and
accessories	Endoscope and
accessories	Endoscope
and
accessories	Endoscope
and
accessories	Same
Substantial Equivalence Comparison Chart
Feature/
Specification	Flex™
Instruments	Covidien SILS
and
Endoscopic
Instruments	Microsurge
Laser Fiber
Holder	United States
Surgical
Corporation
Endoscopic
Needle
Driver	Comparison
Where used
(environment)	Endoscopic
surgical
procedures	Endoscopic
surgical
procedures	Endoscopic
surgical
procedures	Endoscopic
surgical
procedures	Same
Handle design	Pistol Grip or
Wand	Pistol Grip	Wand	Pistol Grip	Same
Articulating
Feature	Yes, ~90°	Yes, ~80°	No	No	Similar with
only minor
differences in
the articulation
range
Tip rotation	Yes, 360°	Yes, 360°	NA	Yes	Same
Manual
Operation for
rotation and
articulation	Yes	Yes	NA	NA	Same
Instrument types	Graspers,
dissectors,
scissors, needle
knife, needle
holder, laser
fiber holder	Graspers,
dissectors,
scissors, L-
hook knife	Laser Fiber
Holder	Endoscopic
Needle Driver	Similar, the
needle knife
function is
similar to the L-
Hook, the laser
holder has
similar design
to the needle
knife but is not
an
electrosurgical
device and
simply holds the
laser fiber for
safe
introduction.
The needle
holder is similar
to the graspers
and dissector
but is not an
electrosurgical
device. These
differences do
not introduce
new concerns
					Page 5 o
Substantial Equivalence Comparison Chart
Feature/
Specification	Flex™
Instruments	Covidien SILS
and
Endoscopic
Instruments	Microsurge
Laser Fiber
Holder	United States
Surgical
Corporation
Endoscopic
Needle
Driver	Comparison
					regarding safety
and
performance.
Device locking
features to hold
articulation
position	Yes	Yes	NA	NA	Same
Minimum
endoscopic
cannula size	4 mm
minimum	5 mm	Unknown	Unknown	Same
Electrosurgical
Function	Yes,
monopolar	Yes,
monopolar	NA	NA	Same
Insertable shaft
length	54 cm (rigid
plus flexible)	36 ad 46 cm	Unknown	Unknown	Minor
difference in
insertion length.
These
differences do
not introduce
new concerns
regarding safety
and
performance.
Shaft Diameter	3.5 mm flexible
section
8 mm rigid
section	Various from
~5-15 mm	Unknown	Unknown	Similar, the
range for the
Flex™
instruments is
more or less
within the range
for the predicate
device.
Shaft flexibility	Flexible
throughout 31
cm length	Flexible at
shaft tip	NA	NA	Similar, both
have flexible
shaft portions.
The Flex™
design can
accommodate a
shaped or
flexible cannula
in addition to a
rigid straight
cannula.
Substantial Equivalence Comparison Chart
Feature/
Specification	Flex™
Instruments	Covidien SILS
and
Endoscopic
Instruments	Microsurge
Laser Fiber
Holder	United States
Surgical
Corporation
Endoscopic
Needle
Driver	Comparison
					Otherwise
function is the
same. These
differences do
not introduce
new concerns
regarding safety
and
performance.
Shaft rotation	360°	360°	NA	360°	Same
How Supplied	Sterile single
use only	Sterile single
use only	Sterile single
use only	Sterile single
use only	Same
Tissue Contact
Materials	Stainless steel,
polymers,
tungsten
brazing,
adhesives,
lubricant, pad
printing ink	Generally:
Stainless steel,
polymers,
adhesives, pad
printing ink	Generally:
Stainless
steel,
polymers,
adhesives,
pad printing
ink	Generally:
Stainless
steel,
polymers,
adhesives,
pad printing
ink	Similar, though
differences may
exists. All
tissue contact
materials in the
Flex™
Instruments
were evaluated
for
biocompatibility
Biocompatibility	Tissue contact
materials are
biocompatible
per ISO 10993	Tissue contact
materials are
biocompatible
per ISO 10993	Tissue
contact
materials are
biocompatible
per ISO
10993	Tissue
contact
materials are
biocompatible
per ISO
10993	Same
Electrosurgical
safety	Complies with
IEC
requirements
for electrical
safety and
electromagnetic
compatibility	Complies with
IEC
requirements
for electrical
safety and
electromagnetic
compatibility	NA	NA	Same
Generator
compatibility
(where
applicable)	Monopolar
generator e.g.
Covidien
ForceTriad™
Energy
Platform or	Monopolar
generator e.g.
Covidien
ForceTriad™
Energy
Platform or	NA	NA	Same
Feature/
Specification	Flex™
Instruments	Covidien SILS
and
Endoscopic
Instruments	Microsurge
Laser Fiber
Holder	United States
Surgical
Corporation

Endoscopic
Needle
Driver | Comparison |
| | equivalent | equivalent | | | |
| Warnings,
cautions, and
contraindications | Stated in IFU | Stated in IFU | Stated in IFU | Stated in IFU | Statements are
similar for both
the subject and
predicate
devices |
| Provided
packaged sterile,
single use only | Yes | Yes | Unknown | Unknown | Same |
| Sterilization | Gamma | Ethylene Oxide | Unknown | Unknown | Same |
| Sterility
Assurance Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | Same |

3

K140662

Page 4 of 7

4

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・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

5

K140662 Page 6 of 7

、

:

.

・ .

6

K140662 Page 7 of 7

The differences between the subject device and the predicate device include minor differences in dimensional characteristics and functional characteristics such as the degree of articulation, length and diameters. The Flex™ Instrument product offering includes a needle driver and a laser fiber holder. These are non-active devices and have similar device features as the rest of the product offering and fall under the general category of endoscopic surgical instruments. Predicate devices have been identified for each. Testing conducted on the Flex™ Instruments demonstrate the safety and performance of these devices for their intended use, further supporting that the differences noted compared to the predicate do not raise new questions of safety and efficacy. The Flex™ Endoscopic Instruments are substantially equivalent to the predicate device.

7

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2014

Design Standards Corporation Ms. Michele Lucey 957 Claremont Road Charlestown, New Hampshire 03603

Re: K140662

Trade/Device Name: Device Name: Flex™ Endoscopic Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, GEI, GEX Dated: March 13, 2014 Received: March 19, 2014

Dear Ms. Lucey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Image /page/7/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center is a stylized image of an eagle or other bird-like figure.

8

Page 2 - Ms. Michele Lucey

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

9

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140662

Device Name

Device Name: Flex™ Endoscopic Instruments

Indications for Use (Describe)

The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in encedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in encedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.

The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY | LAND LE ONLY | 1 1 1 1 1 1 ートの無料など、その他用品になる。 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

10

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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