The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the sternum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.

Device Description

Sterna-Wire is indicated for use in the Sternal Closure. Sterna-Wire is a non absorbable sterile surgical suture composed of 316L stainless steel. The wire material consists of 18" (45cm) 316L stainless steel surgical suture wire and the needle material is a 420 stainless steel sharp semi-circular needle, sterile, nonabsorbable, single use. The product will be packaged as 2 wires, 2 sterna-band and 4 wires, 4 sterna-band and 2 wires, and 2 sterna-band products.

AI/ML Overview

The provided text describes a 510(k) summary for the Stony Brook Surgical Innovations Sterna-Wire, a non-absorbable stainless steel suture. The device is a Class II medical device, and this submission is for substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device is substantially equivalent to the predicate device, Ethi-Pack™ Surgical Stainless Steel Suture. The primary acceptance criteria appear to be compliance with specific non-clinical standards and the absence of new questions regarding safety or effectiveness compared to the predicate.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Material Composition	Identical wire material (18" 316L Stainless Steel Wire) to predicate	Meets: Device uses 18" 316L Stainless Steel Wire
	Identical needle material (420 Stainless Steel Sharp Semi Circular Needle) to predicate	Meets: Device uses 420 Stainless Steel Sharp Semi Circular Needle
Packaging	Consistent with predicate (cardboard sleeve and tyvek pouch)	Meets: Packaging consists of cardboard sleeve and tyvek pouch
Sterilization Method	Identical to predicate (ETO Sterilization)	Meets: Sterilization by ETO
Intended Use	Identical to predicate (median sternotomy closure)	Meets: Indicated for use in Sternal Closure (after median sternotomy)
Non-Clinical Testing	USP 21 Stainless Steel Suture Monographs, Modified	Bench testing performed and supplied with submission, demonstrating no differences in technological characteristics.
	ASTM F899 Standard Designations	Bench testing performed and supplied with submission, demonstrating no differences in technological characteristics.
	AAMI/ANSI/ISO 11137 ETO Sterilization Requirements	Bench testing performed and supplied with submission, demonstrating no differences in technological characteristics.
Safety and Effectiveness	No new questions of safety or effectiveness compared to predicate	Met: "non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness."

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: Not applicable. This submission relies on non-clinical (bench) testing and comparison to a predicate device, not a "test set" of clinical data for performance evaluation in the way a diagnostic device would.
Data Provenance: Not applicable for clinical data. The "test set" in this context refers to the materials and manufacturing processes tested against established standards (USP, ASTM, AAMI/ANSI/ISO). The provenance of these tests would be the manufacturing facility or contract labs where the bench testing was conducted. The document does not specify country of origin for these non-clinical tests. The data is from "bench testing" which is inherently retrospective in nature relative to the submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. The "ground truth" for this type of device (a surgical suture) is established by adherence to recognized material and sterilization standards, and mechanical property testing, rather than expert consensus on diagnostic interpretations. The standards themselves are developed by expert bodies in their respective fields (e.g., USP for pharmacopeial standards, ASTM for materials, ISO for sterilization).

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication process as would be used for clinical diagnostic performance studies. The compliance with standards is typically a pass/fail determination based on established numerical limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not conducted and not applicable. This device is a surgical suture, not a diagnostic imaging or AI-based device that would involve human readers interpreting images.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical medical device (suture), not a software algorithm.

7. Type of Ground Truth Used:

The ground truth used is primarily based on established industry standards and regulatory requirements for materials (e.g., 316L Stainless Steel, 420 Stainless Steel for needles), mechanical properties (implied by USP and ASTM standards for sutures), and sterilization efficacy (AAMI/ANSI/ISO). The substantial equivalence claim is also founded on direct comparison to a legally marketed predicate device with the same intended use and technological characteristics.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or software device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As this is not an AI/software device, there is no training set or associated ground truth establishment process.

Summary

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EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K0\30;59

1. Submitter's Identification:

Stony Brook Surgical Innovations ("SBSI") 25 Asharoken Avenue Northport, NY 11768

Contact: Mr. Marc Leahy

Date Summary Prepared: August 23, 2001

2. Name of the Device:

Stony Brook Surgical Innovations Sterna-Wire (Sternal Sutures)

3. Predicate Device Information:

Ethi-Pack™ Surgical Stainless Steel Suture. Ethicon, Inc., Somerville, NJ, K#931271

4. Device Description:

5. Intended Use:

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Comparison to Predicate Devices: e.

The wire material (18" 316L Stainless Steel Wire) and the needle material (420 Stainless Steel Sharp Semi Circular Needle) are identical between subject and predicate devices. Packaging for both devices consists of cardboard sleeve and tyvek pouch. Sterilization for both devices is by ETO and intended use for both devices is median stenotomy closure. The Ethipak device is packaged in 2, 4 and 6 units, whereas the subject device is packaged in 2 units per package or 2, 4/1 units with the Sterna-Band product.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

USP 21 Stainless Steel Suture Monographs, Modified -
ASTM F899 Standard Designations -
AAMI/ANSI/ISO 11137 ETO Sterilization Requirements -

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

The subject device, Stony Brook Surgical Innovations Sterna-Wire, has the same intended use and characteristics as the predicate device, the Ethi-Pack™ Surgical Stainless Steel Suture. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the Stony Brook Surgical Innovations Sterna-Wire is substantially equivalent to the predicate device, the Ethi-Pack™ Surgical Stainless Steel Suture.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

OCT 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stony Brook Surgical Innovations c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K013059

Trade/Device Name: Sterna-Wire Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: Class II Product Codes: GAQ Dated: September 7, 2001 Received: September 11, 2001

Dear Ms. Goldstein-Falk:

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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Susan Walky wo

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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Exhibit B

Page _ 1 __ of __ 1 __

510(k) Number (if known): K013059

Device Name: Stony Brook Surgical Innovations ("SBSI") Sterna-Wire

Indications For Use:

The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable The Otony Brook Ourgreal Innevached needle that is used during thoracy surgery Otaliness Stool Will of the stemum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)

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

Neurologi
510(k) Number K013059

Regulation Number and Section

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.