Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electronic components for stapling and cutting tissue, with no mention of AI or ML algorithms for analysis, decision-making, or image processing. The "Digital Loading Units" refer to electronic memory for identification and preventing refiring, not AI/ML capabilities.

Therapeutic

No.
The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not a therapeutic device designed to treat a disease or condition directly.

Diagnostic

No

Explanation: The device description clearly states its purpose is for surgical procedures involving resection, transection, and creation of anastomoses by applying staples to tissue. It does not mention any function for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as staplers, loading units, reloads, anvils, cutting blades, a flexible shaft, a power console, and a remote control unit. While there are electronic components (memory module in the reload, electronic remote control), the core function and description revolve around mechanical and physical elements for surgical stapling and cutting. There is no mention of the device being solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states applications in "general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses." This describes a surgical tool used directly on living tissue within the body.
Device Description: The description details a surgical stapler and loading units designed to apply staples and potentially cut tissue during surgery. It describes mechanical components, power sources, and how it interacts with tissue in vivo.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment. The device's function is to perform a surgical procedure directly on the patient.

Therefore, the SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads are surgical devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

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

GDW

Device Description

The devices described here are reloadable Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. All have a maximum diameter of .596" and can be used within a 15 mm cannula. The DLUs are supplied pre-sterilized and ready for use upon removal from their packaging. Reloadable stapling and cutting cartridges are referred to as "Reloads".

Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position layers of tissue in readiness for stapling and cutting. At the same time, the anvil provides support and a means for correctly forming staples while they are closed sequentially along the tissue, followed by the cutting blade, when included. The 15 mm diameter DLUs are axial to the FlexShaft, forming a straight extension to the FlexShaft, to which they are connected.

Loaded Straight Linear Stapler and Straight Linear 4 Row No Knife DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together. Straight Linear Stapler and Straight Linear 4 Row No Knife Reloads contain staples and the means to sequentially force staples toward the anvil. The cutting blade, when included, is advanced immediately behind the staple pushers so that tissue is sequentially stapled and then cut, proceeding from one end of the cartridge to the other.

Straight Linear Stapler DLUs, 55 mm with Blue and Green Reloads have 2 staggered rows of staples on one side of the cutter, coded Blue (1.2 mm) for normal tissue and Green (2.0 mm) for thick tissue. DLUs are available with Blue or Green Reloads installed. Individual Blue and Green Reloads are available.

Straight Linear 4 Row No Knife DLUs, 55 mm with Gray Reloads have two, double-staggered rows of staples, coded Gray (1.2 mm) for normal tissue (same as 55 mm Blue Straight Linear Cutter without the blade). DLUs are available with Gray cartridges installed. "No Knife" distinctively labeled. Individual Gray Reloads are available.

The DLUs are attached to the end of the flexible shaft assembly that contains a pair of flexible rotary drive shafts within an overall flexible tube called the FlexShaft, hereafter referred to as FS. The other end of the FS is connected to a Power Console (PC), which applies mechanical power to the drive shafts.

DLUs have all functions powered by the PC. The FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility.

The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU) that is plugged into the front panel of the PC.

The DLUs have quick attach and release means of coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS, is rotated by hand.

DLU designs allow for attachment of Reloads, but will inhibit attachment of incompatible Reloads. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used and prevents a used Reload from being refired.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal, gynecological, general abdominal and thoracic

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)

Not Found

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.

K020719, K020779

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

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.

Summary

0

K030653 (1 of 7)

MAR 3 1 2003

Special 510(k) Device Modification PREMARKET NOTIFICATION SAFETY AND EFFECTIVENESS SUMMARY

SurgASSIST Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads

In Accordance with 21 CFR section 807.92 Power Medical Interventions, Inc., is submitting the following safety and effectiveness summary.

1. Submitter Information:
  Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax

Applicant:

Barbara J. Whitman

Date of Notification: February 28, 2003

1. Name of Device:

| Trade Name: | SurgASSIST™
Straight Linear Stapler DLU with Reloads
and
Straight Linear 4 Row No Knife DLU
with Reloads |
|--------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name: | Linear Stapler with Implantable Staples
and Reloads |

Classification Name: Staple, Implantable, GDW

1. Predicate Devices:
- A. SurgASSIST™ System with Straight Linear Cutter Digital Loading Units®, 55mm and 30mm with Blue and Green Reloads, with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF SLC55B, SLC55G, SLCR55B, SLCR55G, SLC30B, SLC30G, SLCR30B, SLCR30G. (K020719).

000014

1

030653 (P.2 of 7)

B. Endopath ETS Flex45 No-Knife Articulating Linear Stapler, Ethicon Endo-Surgery, Inc., Cincinnati, OH. REF NAB, NAG. (K020779).
1. Device Description:

The devices described here are reloadable Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. All have a maximum diameter of .596" and can be used within a 15 mm cannula. The DLUs are supplied pre-sterilized and ready for use upon removal from their packaging. Reloadable stapling and cutting cartridges are referred to as "Reloads".

Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position layers of tissue in readiness for stapling and cutting. At the same time, the anvil provides support and a means for correctly forming staples while they are closed sequentially along the tissue, followed by the cutting blade, when included. The 15 mm diameter DLUs are axial to the FlexShaft, forming a straight extension to the FlexShaft, to which they are connected.

Loaded Straight Linear Stapler and Straight Linear 4 Row No Knife DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together. Straight Linear Stapler and Straight Linear 4 Row No Knife Reloads contain staples and the means to sequentially force staples toward the anvil. The cutting blade, when included, is advanced immediately behind the staple pushers so that tissue is sequentially stapled and then cut, proceeding from one end of the cartridge to the other.

Straight Linear Stapler DLUs, 55 mm with Blue and Green Reloads have 2 staggered rows of staples on one side of the cutter, coded Blue (1.2 mm) for normal tissue and Green (2.0 mm) for thick tissue. DLUs are available with Blue or Green Reloads installed. Individual Blue and Green Reloads are available.

Straight Linear 4 Row No Knife DLUs, 55 mm with Gray Reloads have two, double-staggered rows of staples, coded Gray (1.2 mm) for normal tissue (same as 55 mm Blue Straight Linear Cutter without the blade). DLUs are available with Gray cartridges installed. "No Knife" distinctively labeled. Individual Gray Reloads are available.

The DLUs are attached to the end of the flexible shaft assembly that contains a pair of flexible rotary drive shafts within an overall flexible tube called the FlexShaft, hereafter referred to as FS. The other end of the FS is connected to a Power Console (PC), which applies mechanical power to the drive shafts.

2

DLUs have all functions powered by the PC. The FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility.

The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU) that is plugged into the front panel of the PC.

The DLUs have quick attach and release means of coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS, is rotated by hand.

DLU designs allow for attachment of Reloads, but will inhibit attachment of incompatible Reloads. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used and prevents a used Reload from being refired.

1. Indications For Use
  The SuraASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
1. Comparison to Predicate Devices
  The following table compares the subject Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads to the previously cleared predicate Straight Linear Cutter Digital Loading Units® with Reloads (K020719).

3

Pow. Medical Interventions, Inc.
SurgASSIST™ Straight Linear Stapler DLUs with Reloads
Special 510(k) Device Modification PreMarket Notification, February 28, 20

Straight Linear Stapler DLU Product Features Comparison Cha

Features & Description	Name	Predicate
SurgASSIST™
Straight Linear Stapler, 55 mm
With Blue and Green Reloads and
Straight Linear 4 Row No Knife
Digital Loading Units® (DLUs)	SurgASSIST™
Straight Linear Stapler DLUs, 55 mm
with Blue and Green Reloads and
Straight Linear 4 Row No Knife DLUs	SurgASSIST™
Straight Linear Cutter DLUs,
55 mm and 30 mm with Blue and
Green Reloads	Ethicon Endo-Surgery, Inc.
Endopath ETS Flex45 No-Knife
Articulating Linear Stapler	SurgASSISTTM
Straight Linear Stapler, 55 mm
With Blue and Green Reloads and
Straight Linear 4 Row No Knife
Digital Loading Units® (DLUs)	SurgASSISTTM
Straight Linear Cutter DLUs,
55 mm and 30 mm with Blue and
Green Reloads	Ethicon Endo-Surgery, Inc.
Endopath ETS Flex45 No-Knife
Articulating Linear Stapler
		SurgASSIST™
Straight Linear Cutter DLUs, 55 mm and
30 mm with Blue and Green Reloads	Endopath ETS Flex45 No-Knife
Articulating Linear Stapler	Do not use the SurgASSISTTM Straight
Linear Stapler DLU, 55mm Blue, on any
tissue that requires excessive force to
compress to 1.5 mm or on any tissue
that compresses easily below 1.5 mm.

Do not use the SurgASSISTTM Straight
Linear Stapler DLU, 55 mm Green, on
any tissue that requires excessive force
to compress to 2.3 mm or on any tissue
that compresses easily below 2.3 mm.

Do not use the SurgASSISTTM Straight
Linear 4 Row No Knife DLU, (Gray), on
any tissue that requires excessive force
to compress to 1.5 mm or on any tissue
that compresses easily below 1.5 mm. | Do not use the SurgASSISTTM System
Straight Linear Cutter DLU, 55 mm,
30 mm where combined tissue
thickness exceeds 2.3 mm or is less
than 1.0 mm. | Do not use the instrument with blue
reload on any tissue that requires
excessive force to compress to 1.5 mm
or on any tissue that compresses easily
to below 1.5 mm.

Do not use on ischemic or necrotic
tissue.

Do not use the instruments on the aorta.
Do not use any linear cutter on major
vessels without making provision for
proximal and distal control.
Do not use the instrument on solidorgans, such as liver or spleen, where
attempted compression would be
destructive.
These instruments are not intended for
use when surgical stapling is
contraindicated.
Do not use the instruments with green
reload on any tissue that requires
excessive force to compress to 2.0 mm
or on any tissue that compresses easily
to below 2.0 mm. | |
| Manufacturer of Record | Power Medical Interventions, Inc. | Power Medical Interventions, Inc. | Ethicon Endo-Surgery, Inc | FDA Class (System) | | | |
| Contract Manufacturer | The MedTech Group
South Plainfield, NJ | The MedTech Group
South Plainfield, NJ | Ethicon Endo-Surgery, Inc | Number of Staples | SLS55B, SLSR55B - 28 staples
SLS55G, SLSR55G - 28 staples
SLS55B4, SLSR55B4 - 56 staples | SLC55B, SLCR55B - 56 staples
SLC55G, SLCR55G - 56 staples
SLC30B, SLCR30B - 32 staples
SLC30G, SLCR30G - 32 staples | NAB - 44 staples
NAG - 44 staples |
| 510(k) Clearance Numbers | Subject of this Notification | K020719 | K020779 | | | | |
| Product Codes | SLS55B, SLSR55B, SLS55G,
SLSR55G, SLS55B4, SLSR55B4 | SLC55B, SLCR55B, SLC55G,
SLCR55G, SLC30B, SLCR30B,
SLC30G, SLCR30G | NAB45 and NAG45 | | | | |
| Intended use | Have applications for general and
endoscopic surgery in gastrointestinal,
gynecological, general abdominal and
thoracic surgical procedures for
resection, transection, and creation of
anastomoses. | Have applications for general and
endoscopic surgery in gastrointestinal,
gynecological, general abdominal and
thoracic surgical procedures for
resection, transection, and creation of
anastomoses. | Intended for transection, resection,
and/or creation of anastomoses. The
instruments have application in multiple
open or minimally invasive general,
gynecologic, urologic (including radical
prostatectomy), thoracic, and pediatric
surgical procedures. They can be used
with staple line or tissue buttressing
materials such as bovine pericardium. | | | | |

K 030653 (P.4 of 7)

000017

4

Pow. Medical Interventions, Inc.
SurgASSIST™ Straight Linear Stapler DLUs with Reloads
Special 510(k) Device Modification PreMarket Notification, February 28, 2

Straight Linear Stapler DLU Product Features Comparison Cham

K030653 (P.Sofm)

5

Pow.. Medical Interventions, Inc.
SurgASSIST™ Straight Linear Stapler DLUs with Reloads
Special 510(k) Device Modification PreMarket Notification, February 28, 20

raight Linear Stapler DLU Product Features Comparison Cham

| Features & Description | SurgASSIST™
Straight Linear Stapler, 55 mm
With Blue and Green Reloads and
Straight Linear 4 Row No Knife
Digital Loading Units® (DLUs) | Predicate
SurgASSIST™
Straight Linear Cutter DLUs,
55 mm and 30 mm with Blue and
Green Reloads | Predicate
Ethicon Endo-Surgery, Inc.
Endopath ETS Flex45 No-Knife
Articulating Linear Stapler |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Rows of Staples | SLS55B, SLSR55B - 2 rows
SLS55G, SLSR55G - 2 rows
SLS55B4, SLSR55B4 - 4 rows | SLC55B, SLCR55B - 4 rows
SLC55G, SLCR55G - 4 rows
SLC30B, SLCR30B - 4 rows
SLC30G, SLCR30G - 4 rows | NAB - 4 rows
NAG - 4 rows |
| Knife/Scalpel | SLS55B, SLSR55B - scalpel included
SLS55G, SLSR55G - scalpel included
SLS55B4, SLSR55B4 - NO KNIFE | SLC55B, SLCR55B - scalpel included
SLC55G, SLCR55G - scalpel included
SLC30B, SLCR30B - scalpel included
SLC30G, SLCR30G - scalpel included | NAB - NO KNIFE
NAG - NO KNIFE |
| Staple Diameter | SLS55B, SLSR55B - .21 mm
SLS55G, SLSR55G - .23 mm
SLS55B4 - .21 mm | SLC55B, SLCR55B - .21 mm
SLC55G, SLCR55G - .23 mm
SLC30B, SLCR30B - .23 mm
SLC30G, SLCR30G - .23 mm | NAB - .23 mm
NAG - .23 mm |
| Staple Height | SLS55B, SLSR55B - 1.2 mm
SLS55G, SLSR55G - 2.0 mm
SLS55B4 - 1.2 mm | SLC55B, SLCR55B - 1.2 mm
SLC55G, SLCR55G - 2.0 mm
SLC30B, SLCR30B - 1.2 mm
SLC30G, SLCR30G - 2.0 mm | NAB - 1.5 mm
NAG - 2.0 mm |
| DLU Internal Power | None | None | None |
| Digital Information | Memory module containing digital data
for identification, etc. | Memory module containing digital data
for identification, etc. | None |
| How Supplied | Sterile - Single Patient Use | Sterile - Single Patient Use | Sterile - Single Patient Use |

000019

03d6S3(f.6of7)

6

Pow

traight Linear Stapler DLU Product Features Comparison Cha

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.

Features & Description	Method of Sterilization	Digital Loading Unit®	Reloads
SurgASSIST™™
Straight Linear Stapler, 55 mm
with Blue and Green Reloads and
Straight Linear 4 Row No Knife
Digital Loading Units® (DLUS)	Ethylene Oxide Gas (ETO)	Blister Tray
with Tyvek Lid	Tyvek Pouch
Predicate
SurgASSIST™™
Straight Linear Cutter DLUs,
55 mm and 30 mm with Blue and
Green Reloads	Ethylene Oxide Gas (ETO)	Blister Tray with
Tyvek Lid	Tyvek Pouch
Predicate
Ethicon Endo-Surgery, Inc.
Endopath ETS Flex45 No-Knife
Articulating Linear Stapler	Irradiation	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid

Image /page/6/Picture/5 description: The image contains handwritten text that appears to be an alphanumeric code or identifier. The text reads "KU30653(F.70P7)". The characters are written in a cursive style, and the text is slightly slanted.

7

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2003

Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938

Re: K030653

Trade/Device Name: SurgASSIST™ Straight Linear Stapler Digital Loading Unit® with Reloads and Straight Linear 4 Row No Knife Digital Loading Unit® with Reloads

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: February 28, 2003 Received: March 3, 2003

Dear Ms. Whitman:

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 (PMA), 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 (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.

8

Page 2 - Ms. Barbara J. Whitman

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

9

Power Medical Interventions, Inc. New Hope, PA 18938

510(k) No. K K934653

Device Name:

SurgASSIST™ Straight Linear Stapler Digital Loading Unit® with Reloads And Straight Linear 4 Row No Knife Digital Loading Unit® with Reloads

INDICATIONS FOR USE:

The SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use Per 21CFR §801.109

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Phrost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

OR

510(k) Number_________________________________________________________________________________________________________________________________________________________________

000012