The Dual Needle Suture Passer System is a sterile hand-held, manually operated single procedure suture placement system for soft tissue approximation procedures.

AI/ML Overview

The provided text describes the 510(k) summary for the Dual Needle Suture Passer System. The study conducted to demonstrate equivalence is a mechanical test rather than a clinical study involving human or animal subjects that would typically have the detailed information requested.

Here's the information extracted and filled in to the best of what's available in the text:

Device: Dual Needle Suture Passer System

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Suture knot pull-out strength significantly higher than a predicate device	Suture knot pull-out strength is significantly higher than that of a predicate device.
Meet knot pull-out strength requirements in animal tissue	The proposed device was tested in animal tissue and meets the knot pull-out strength requirements.
Meet USP requirements for non-absorbable sutures	The proposed device meets USP requirements for non-absorbable sutures.

Study Details:

Sample size used for the test set and the data provenance:
- The document implies a test set was used for mechanical testing of suture knot pull-out force in "animal tissue." No specific number of samples or animal subjects is provided.
- Data provenance: "animal tissue" is mentioned, not a specific country. The study appears to be a laboratory/benchtop test rather than a clinical study. It is a retrospective comparison against a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical engineering/biomedical performance test, not a study requiring expert consensus for ground truth.
Adjudication method for the test set:
- Not applicable, as there was no expert review or human assessment of ground truth. The acceptance criteria were based on quantitative mechanical measurements.
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:
- No, an MRMC study was not done. This device is a surgical instrument, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm.
The type of ground truth used:
- The "ground truth" for this study was defined by established mechanical engineering standards (e.g., USP requirements) and direct comparison to a predicate device's performance through quantitative mechanical testing (suture knot pull-out force).
The sample size for the training set:
- Not applicable. This was a mechanical performance study, not a machine learning study involving training data.
How the ground truth for the training set was established:
- Not applicable. This was a mechanical performance study, not a machine learning study involving training data.

Summary

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K082518

Dual Needle Suture Passer

Page 1 of 2

510(k) Premarket Notification

Dual Needle Suture Passer

510(k) Summary

Cayenne Medical, Inc. Dual Needle Suture Passer System JAN 1 6 2009

ADMINISTRATIVE INFORMATION

Manufacturer Name	Cayenne Medical Inc16597 N 92nd St, Suite 101Scottsdale, AZ 85260Telephone (480) 502-3661FAX (480) 502-3670
Official Contact	Kereshmeh Shahriari16597 N 92nd St, Suite 101Scottsdale AZ 85260kshahriari@cayennemedical.comTelephone (480) 502-3661FAX (480) 502-3670

DEVICE NAME

Classification Names	Suture, Nonabsorbable, Synthetic, Polyethylene
Trade/Proprietary Name	Dual Needle Suture Passer System
Common Name	Suture Punch, Endoscopic Accessories

DEVICE CLASSIFICATION

FDA has classified sutures as Class II devices (21 CFR 878 5000) The product code for Suture, Nonabsorbable, Synthetic, Polyethylene is GAT These devices are reviewed by the General and Plastic Surgery Branch

INTENDED USE

The Dual Needle Suture Passer System is intended for approximation of soft tissue in procedures such as memscal repair

DANGER!

Page 109 & 110

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Dual Needle Suture Passer

Response,

Page ② of ②

510(k) Premarket Notification

Dual Needle Suture Passer

DEVICE DESCRIPTION

The Dual Needle Suture Passer System is a sterle hand-held, manually operated sungle procedure suture placement system for soft tissue approximation procedures

Mechanical suture knot pull-out force testing has been conducted on the Dual Needle Suture Passer System It was shown that suture knot pull-out strength is significantly higher than that of a predicate device The proposed device was tested in the animal trsue and meets the knot pull-out strength requirements The proposed device meets USP requirements for non-absorbable sutures

EQUIVALENCE TO MARKETED PRODUCT

Cayenne Medical, Inc demonstrated that for the purposes of FDA's regulation of medical devices, the Dual Needle Suture Passer System is substantially equivalent 111 indications and design principles to predicate devices each of which has been determined by FDA to be substantially equivalent to preamendment devices Teleflex Medical's Force Fiber™, Non-absorbable Polyethylene Surgical Suture (K063778), CP Medical's CP Fiber Non-absorbable Polyblended Surgical Suture (K041894), DePuy Mitek's (Mitek Worldwide) RAPIDLOC-PDS Mensical Repair System (K023388), Anulex Technologies's Xclose™ Tissue Repair System (K062307), and Smith & Nephew s ULTRA FAST-FIX Memscal Repair System (K072322)

Revised Page 18 of 161

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Admınıstration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2009

Cayenne Medical, Inc % Kereshmeh Shahrıarı Director of QA & RA 16597 N 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re K082518

Trade/Device Name Dual Needle Suture Passer System Regulation Number 21 CFR 878 5000 Regulation Name Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class II Product Code GAT Dated December 22, 2008 Received December 23, 2008

Dear Kereshmeh Shahrıarı

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 pror 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

and the stille

all to the mail be a chiefic to and the legist of the leating the

2017-12-11-11

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Page 2 - Kereshmeh Shahrıarı

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 (240) 276-0115 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 Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www.fda gov/cdrh/industry/support/index.html

Sincerely yours.

Mark N Millican

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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17000558

510(k) Premarket Notification

Dual Needle Suture Passer

Indications for Use

510(k) Number (if known) K072518

Device Name Dual Needle Suture Passer System

Indications for Use

The Dual Needle Suture Passer System is intended for approximation of soft tissue 11 procedures such as meniscal repar

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)

서 대한민국 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	16082518
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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.