CAPSEW PLICATION SYSTEM

• K Number: K071796
• Device Name: CAPSEW PLICATION SYSTEM
• Manufacturer: CAYENNE MEDICAL, INC.
• Date Cleared: 2007-10-19 ( 109 days)
• Product Code: GAT
• Regulation Number: 878.5000
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K042031 , K041894 , K063778 , K001434
• Predicate For: N/A

Intended Use

The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures including shoulder capsule tightening.

Device Description

The CapSew"" Plication System is a sterile hand-held, manually operated, single procedure suture placement system for shoulder capsule tightening (plication) procedures. The CapSew Plication System includes one CapSew Plication Device (consisting of a Plication Handle with mounted Suture Cartridge) and one additional CapSew" Suture Cartridge.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CapSew™ Plication System, a medical device for placing sutures. However, it does not contain the detailed acceptance criteria and study information typically found in a clinical trial report or a performance validation study for a device.

The document primarily focuses on:

• Administrative Information: Manufacturer, contact, device name, classification, and intended use.
• Device Description: A brief physical description of the CapSew™ Plication System.
• Performance Testing: A high-level statement that "Mechanical testing has been conducted and data was submitted to demonstrate that the performance of the CapSew™ Plication System is equivalent to that of predicate devices."
• Equivalence to Marketed Product: Listing of predicate devices to which the CapSew™ Plication System is considered substantially equivalent.
• FDA Communication: The FDA's substantial equivalence letter, confirming the device can be marketed.
• Indications for Use: The approved indications for the device.

Based on the provided text, I cannot extract the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The submission is a 510(k) for a Class II device, which often relies on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design principles, rather than extensive clinical trials with detailed performance metrics against predefined acceptance criteria. The statement about "Mechanical testing" suggests that performance was evaluated against engineering specifications related to the device's function (e.g., suture placement strength, device durability), but the specific criteria and results are not included in this summary.

Therefore, I cannot populate the table or answer the specific questions because the necessary details are not present in the provided document.

Summary

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K071796 page 1/2

510(k) Premarket Notification

CapSew™ Plication System

510(k) Summary

0CT 1 9 2007

Cayenne Medical, Inc. CapSew™ Plication System

ADMINISTRATIVE INFORMATION

Manufacturer Name: Cayenne Medical, Inc. 16597 North 92nd Street, Suite 101 Scottsdale, AZ 85260 USA Telephone [phone] Fax [phone]

Official Contact:

Derek Harper

Representative/Consultant:

David J. Collette MD or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone] email: [e-mail] [e-mail]

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations: Product Codes Classification Panel: Reviewing Branch:

CapSew™ Plication System Suture punch, endoscopic accessories 21 CFR 878.5000, Class II GAT General and Plastic Surgery General and Plastic Surgery

INTENDED USE

The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures including shoulder capsule tightening.

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K07179

ge 2/2

CapSew " Plication System

DEVICE DESCRIPTION

The CapSew"" Plication System is a sterile hand-held, manually operated, single procedure suture placement system for shoulder capsule tightening (plication) procedures. The CapSew Plication System includes one CapSew Plication Device (consisting of a Plication Handle with mounted Suture Cartridge) and one additional CapSew" Suture Cartridge.

PERFORMANCE TESTING

Mechanical testing has been conducted and data was submitted to demonstrate that the performance of the CapSew™ Plication System is equivalent to that of predicate devices.

EQUIVALENCE TO MARKETED PRODUCT

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the CapSew" Plication System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Opus Medical, Inc.'s Opus SpeedStitch™ Suture Device (K042031), CP Medical's CP Fiber, Non-Absorbable Polyblend Surgical Suture (K041894), Teleflex Medical's Force Fiber® Polyethylene Non-Absorbable Surgical Suture (K063778), and Genzyme Surgical Products Polyester Nonabsorbable Surgical Suture (K001434).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JAN - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cayenne Medical, Inc % PaxMed International, LLC David J. Collette, MD Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K071796

Trade/Device Name: CapSew™ Plication System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: September 26, 2007 Received: October 1, 2007

Dear Dr. Collette:

This letter corrects our substantially equivalent letter of October 19, 2007.

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

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Page 2 - David J. Collette, MD

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prostmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

CapSew™ Plication System Device Name:

Indications for Use:

The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures.

Maida A. Milhersen

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

510(k) Number K071796

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.