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.

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.

AI/ML Overview

The provided documentation describes a Special 510(k) Device Modification for the SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads. This type of submission is typically for modifications to an already cleared device and often relies on demonstrating substantial equivalence to a predicate device rather than conducting a full de novo study with explicit acceptance criteria and performance metrics.

Based on the provided text, there is no explicit mention of quantitative acceptance criteria or a dedicated study (e.g., a clinical trial or a formal performance study with statistical endpoints) designed to prove the device meets specific performance targets beyond demonstrating substantial equivalence to predicate devices.

Instead, the document focuses on:

Device Description: Detailing the components and function of the modified staplers and reloads.
Indications for Use: Stating the surgical procedures for which the device is intended.
Comparison to Predicate Devices: Highlighting similarities and differences with previously cleared staplers (K020719 and K020779). This comparison forms the primary basis for demonstrating safety and effectiveness for a 510(k) submission.

Therefore, many of the requested items related to acceptance criteria and study details cannot be fully extracted from this document, as they were likely not part of this specific submission's scope.

Here's a breakdown of the information that can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance:

As explicitly stated above, the document does not provide a table of quantitative acceptance criteria or reported device performance in terms of specific metrics (e.g., stapling success rate, leak rates, tissue compression consistency) from a dedicated study. The "acceptance criteria" for a 510(k) modification are typically met by demonstrating that the modified device is as safe and effective as (substantially equivalent to) the predicate device, which is primarily done through detailed comparison of features, materials, and intended use.

The comparison tables (pages 3-6) focus on comparing device features like:

Features & Description	SurgASSIST™ Straight Linear Stapler DLUs with Reloads (Subject Device)	Predicate SurgASSIST™ Straight Linear Cutter DLUs	Predicate Ethicon Endo-Surgery, Inc. Endopath ETS Flex45 No-Knife Articulating Linear Stapler
Intended Use	General and endoscopic surgery... resection, transection, anastomoses.	General and endoscopic surgery... resection, transection, anastomoses.	Transection, resection, and/or creation of anastomoses.
Number of Staples	SLS55B, SLSR55B - 28 staplesSLS55G, SLSR55G - 28 staplesSLS55B4, SLSR55B4 - 56 staples	SLC55B, SLCR55B - 56 staplesSLC55G, SLCR55G - 56 staplesSLC30B, SLCR30B - 32 staplesSLC30G, SLCR30G - 32 staples	NAB - 44 staplesNAG - 44 staples
Rows of Staples	SLS55B, SLSR55B - 2 rowsSLS55G, SLSR55G - 2 rowsSLS55B4, SLSR55B4 - 4 rows	SLC55B, SLCR55B - 4 rowsSLC55G, SLCR55G - 4 rowsSLC30B, SLCR30B - 4 rowsSLC30G, SLCR30G - 4 rows	NAB - 4 rowsNAG - 4 rows
Knife/Scalpel	SLS55B, SLSR55B - scalpel includedSLS55G, SLSR55G - scalpel includedSLS55B4, SLSR55B4 - NO KNIFE	SLC55B, SLCR55B - scalpel includedSLC55G, SLCR55G - scalpel includedSLC30B, SLCR30B - scalpel includedSLC30G, SLCR30G - scalpel included	NAB - NO KNIFENAG - NO KNIFE
Staple Diameter	SLS55B, SLSR55B - .21 mmSLS55G, SLSR55G - .23 mmSLS55B4 - .21 mm	SLC55B, SLCR55B - .21 mmSLC55G, SLCR55G - .23 mmSLC30B, SLCR30B - .23 mmSLC30G, SLCR30G - .23 mm	NAB - .23 mmNAG - .23 mm
Staple Height	SLS55B, SLSR55B - 1.2 mmSLS55G, SLSR55G - 2.0 mmSLS55B4 - 1.2 mm	SLC55B, SLCR55B - 1.2 mmSLC55G, SLCR55G - 2.0 mmSLC30B, SLCR30B - 1.2 mmSLC30G, SLCR30G - 2.0 mm	NAB - 1.5 mmNAG - 2.0 mm
How Supplied	Sterile - Single Patient Use	Sterile - Single Patient Use	Sterile - Single Patient Use
Method of Sterilization	Ethylene Oxide Gas (ETO)	Ethylene Oxide Gas (ETO)	Irradiation

The document states "The DLUs have all functions powered by the PC" and "The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU)". This indicates performance relies on the entire system. Limitations for use based on tissue thickness are also provided in a comparative table.

2. Sample size used for the test set and the data provenance: Not applicable. No dedicated "test set" or clinical study is described within this document for performance evaluation. This is a 510(k) modification where substantial equivalence is demonstrated through comparison to predicates and likely engineering testing (not detailed here).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific expert review for establishing ground truth for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical stapler, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary from the document's perspective:

The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence is the comparison to predicate devices (K020719 and K020779) as detailed in the submission. The acceptance criterion for this 510(k) modification is that the modified device is as safe and effective as legally marketed predicate devices. This is demonstrated by showing that the subject device shares the same intended use, similar technological characteristics (staple length, diameter, rows, knife presence, sterilization method), and comparable performance characteristics (though specific performance metrics from new studies are not provided in this excerpt). The FDA's letter (K030653) confirms that they reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.

Summary

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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 ReloadsandStraight Linear 4 Row No Knife DLUwith Reloads
Common Name:	Linear Stapler with Implantable Staplesand 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

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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:

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.

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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).

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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	Predicate	Features & Description	Predicate	Predicate
SurgASSIST™Straight Linear Stapler, 55 mmWith Blue and Green Reloads andStraight Linear 4 Row No KnifeDigital Loading Units® (DLUs)	SurgASSIST™Straight Linear Stapler DLUs, 55 mmwith Blue and Green Reloads andStraight Linear 4 Row No Knife DLUs	SurgASSIST™Straight Linear Cutter DLUs,55 mm and 30 mm with Blue andGreen Reloads	Ethicon Endo-Surgery, Inc.Endopath ETS Flex45 No-KnifeArticulating Linear Stapler	SurgASSISTTMStraight Linear Stapler, 55 mmWith Blue and Green Reloads andStraight Linear 4 Row No KnifeDigital Loading Units® (DLUs)	SurgASSISTTMStraight Linear Cutter DLUs,55 mm and 30 mm with Blue andGreen Reloads	Ethicon Endo-Surgery, Inc.Endopath ETS Flex45 No-KnifeArticulating Linear Stapler
		SurgASSIST™Straight Linear Cutter DLUs, 55 mm and30 mm with Blue and Green Reloads	Endopath ETS Flex45 No-KnifeArticulating Linear Stapler	Do not use the SurgASSISTTM StraightLinear Stapler DLU, 55mm Blue, on anytissue that requires excessive force tocompress to 1.5 mm or on any tissuethat compresses easily below 1.5 mm.Do not use the SurgASSISTTM StraightLinear Stapler DLU, 55 mm Green, onany tissue that requires excessive forceto compress to 2.3 mm or on any tissuethat compresses easily below 2.3 mm.Do not use the SurgASSISTTM StraightLinear 4 Row No Knife DLU, (Gray), onany tissue that requires excessive forceto compress to 1.5 mm or on any tissuethat compresses easily below 1.5 mm.	Do not use the SurgASSISTTM SystemStraight Linear Cutter DLU, 55 mm,30 mm where combined tissuethickness exceeds 2.3 mm or is lessthan 1.0 mm.	Do not use the instrument with bluereload on any tissue that requiresexcessive force to compress to 1.5 mmor on any tissue that compresses easilyto below 1.5 mm.Do not use on ischemic or necrotictissue.Do not use the instruments on the aorta.Do not use any linear cutter on majorvessels without making provision forproximal and distal control.Do not use the instrument on solidorgans, such as liver or spleen, whereattempted compression would bedestructive.These instruments are not intended foruse when surgical stapling iscontraindicated.Do not use the instruments with greenreload on any tissue that requiresexcessive force to compress to 2.0 mmor on any tissue that compresses easilyto 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 GroupSouth Plainfield, NJ	The MedTech GroupSouth Plainfield, NJ	Ethicon Endo-Surgery, Inc	Number of Staples	SLS55B, SLSR55B - 28 staplesSLS55G, SLSR55G - 28 staplesSLS55B4, SLSR55B4 - 56 staples	SLC55B, SLCR55B - 56 staplesSLC55G, SLCR55G - 56 staplesSLC30B, SLCR30B - 32 staplesSLC30G, SLCR30G - 32 staples	NAB - 44 staplesNAG - 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 andendoscopic surgery in gastrointestinal,gynecological, general abdominal andthoracic surgical procedures forresection, transection, and creation ofanastomoses.	Have applications for general andendoscopic surgery in gastrointestinal,gynecological, general abdominal andthoracic surgical procedures forresection, transection, and creation ofanastomoses.	Intended for transection, resection,and/or creation of anastomoses. Theinstruments have application in multipleopen or minimally invasive general,gynecologic, urologic (including radicalprostatectomy), thoracic, and pediatricsurgical procedures. They can be usedwith staple line or tissue buttressingmaterials such as bovine pericardium.

K 030653 (P.4 of 7)

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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)

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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 mmWith Blue and Green Reloads andStraight Linear 4 Row No KnifeDigital Loading Units® (DLUs)	PredicateSurgASSIST™Straight Linear Cutter DLUs,55 mm and 30 mm with Blue andGreen Reloads	PredicateEthicon Endo-Surgery, Inc.Endopath ETS Flex45 No-KnifeArticulating Linear Stapler
Rows of Staples	SLS55B, SLSR55B - 2 rowsSLS55G, SLSR55G - 2 rowsSLS55B4, SLSR55B4 - 4 rows	SLC55B, SLCR55B - 4 rowsSLC55G, SLCR55G - 4 rowsSLC30B, SLCR30B - 4 rowsSLC30G, SLCR30G - 4 rows	NAB - 4 rowsNAG - 4 rows
Knife/Scalpel	SLS55B, SLSR55B - scalpel includedSLS55G, SLSR55G - scalpel includedSLS55B4, SLSR55B4 - NO KNIFE	SLC55B, SLCR55B - scalpel includedSLC55G, SLCR55G - scalpel includedSLC30B, SLCR30B - scalpel includedSLC30G, SLCR30G - scalpel included	NAB - NO KNIFENAG - NO KNIFE
Staple Diameter	SLS55B, SLSR55B - .21 mmSLS55G, SLSR55G - .23 mmSLS55B4 - .21 mm	SLC55B, SLCR55B - .21 mmSLC55G, SLCR55G - .23 mmSLC30B, SLCR30B - .23 mmSLC30G, SLCR30G - .23 mm	NAB - .23 mmNAG - .23 mm
Staple Height	SLS55B, SLSR55B - 1.2 mmSLS55G, SLSR55G - 2.0 mmSLS55B4 - 1.2 mm	SLC55B, SLCR55B - 1.2 mmSLC55G, SLCR55G - 2.0 mmSLC30B, SLCR30B - 1.2 mmSLC30G, SLCR30G - 2.0 mm	NAB - 1.5 mmNAG - 2.0 mm
DLU Internal Power	None	None	None
Digital Information	Memory module containing digital datafor identification, etc.	Memory module containing digital datafor identification, etc.	None
How Supplied	Sterile - Single Patient Use	Sterile - Single Patient Use	Sterile - Single Patient Use

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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 mmwith Blue and Green Reloads andStraight Linear 4 Row No KnifeDigital Loading Units® (DLUS)	Ethylene Oxide Gas (ETO)	Blister Traywith Tyvek Lid	Tyvek Pouch
PredicateSurgASSIST™™Straight Linear Cutter DLUs,55 mm and 30 mm with Blue andGreen Reloads	Ethylene Oxide Gas (ETO)	Blister Tray withTyvek Lid	Tyvek Pouch
PredicateEthicon Endo-Surgery, Inc.Endopath ETS Flex45 No-KnifeArticulating 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.

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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.

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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

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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:

(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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

000012

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.