The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.

Device Description

The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SuturTek FASTCLOSE Sternum Closure Device. It details the device, its intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or the other requested information for the device's performance.

Based on the provided information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document.
Reported Device Performance: The document only states "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended." No specific performance metrics or results are provided.

2. Sample sized used for the test set and the data provenance

This information is not provided in the document. The document mentions "Bench testing," but no details on sample size or data provenance are included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Bench testing typically does not involve expert-established ground truth in the same way clinical studies or image-based AI studies do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically relevant for human review of data, which is not described for this device's testing.

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

This information is not provided in the document. The device is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. The device is a manual instrument, so "standalone" performance in the context of an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. For bench testing of a surgical device, ground truth would likely refer to engineering specifications or mechanical performance metrics, but these are not detailed.

8. The sample size for the training set

This information is not provided in the document. The device is a physical instrument, so a "training set" in the context of machine learning is not applicable.

9. How the ground truth for the training set was established

This information is not provided in the document. As above, a "training set" is not relevant for this type of device.

Summary Table of Available Information:

Information Category	Details
Acceptance Criteria & Reported Performance	Acceptance Criteria: Not explicitly stated. Reported Device Performance: "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended." No specific metrics or quantitative results are provided.
Sample size for test set & Data provenance	Not provided.
Experts used for ground truth (test set) & Qualifications	Not provided.
Adjudication method for test set	Not provided.
MRMC comparative effectiveness study & Effect size	Not applicable (device is a surgical instrument, not AI-assisted).
Standalone (algorithm only) performance	Not applicable (device is a surgical instrument).
Type of ground truth used	Not provided in detail. For bench testing, it would likely involve engineering specifications or mechanical stability, but specific methods (e.g., tensile strength, fatigue testing results) are not mentioned.
Sample size for training set	Not applicable (device is a surgical instrument, not an algorithm).
How ground truth for training set was established	Not applicable.

General Conclusion:

The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence to predicate devices and describes the device's design and intended use. It confirms that "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended," but it does not include the detailed performance data, acceptance criteria, or study methodologies that would be required to answer most of your specific questions. This level of detail is often found in the full 510(k) submission, but not typically in the publicly available summary.

Summary

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SEP 2 3 2003

K032468 P1/2

FASTCLOSE™ Sternum Closure Device

SuturTek Incorporated 510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness SuturTek FASTCLOSE Sternum Closure Device August 8, 2003

Sponsor Name Sponsor/Manufacturer: SuturTek Incorporated 51 Middlesex Street North Chelmsford, Massachusetts 01863 Telephone: 978-251-8088 FAX: 978-251-8585

2. Device Name

Proprietary Name: FASTCLOSE™ Sternum Closure Device

Common/Usual Name: Suture, Nonabsorbable, Steel, Monofilament And Multifilament

Panel: General Surgery Product Code: GAQ 878.4495 - Suture, Nonabsorbable, Steel, Monofilament And Multifilament

Identification of Predicate or Legally Marketed Device 3. SuturTek FASTCLOSE Fascia Closure Device K011105 SuturTek FASTCLOSE Fascia Closure Device K030227 Aesculap Steelex Sternum Set K023411

Device Description র্বা

The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

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KO32468$_{B2/2}$

SuturTek Incorporated 510(k) Premarket Notification FASTCLOSE™ Sternum Closure Device

న్. Intended Use

The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy.

It is designed to aid in the prevention of suture needlestick injuries.

Comparison of Technological Characteristics 6.
The FASTCLOSE Sternum Closure Device is substantially equivalent in its intended use and/or function to the following predicate devices:

SuturTek FASTCLOSE Fascia Closure Device K011105 SuturTek FASTCLOSE Fascia Closure Device K030227 Aesculap Steelex Sternum Set K023411

The operating principle, materials, intended use and design of construction of the FASTCLOSE Sternum Closure Device is the same as that of the predicate devices: a manual instrument is used to pass stainless steel needles through sternum for fixation with stainless steel sutures.

7 Performance Testing
Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SuturTek, Inc. c/o Ms. Debbie lampietro ORC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K032468

Trade/Device Name: FASTCLOSE Sternum Closure Device Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: August 8, 2003 Received: August 19, 2003

Dear Ms. Iampietro:

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. Debbie Iampietro

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. 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 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.

iriam 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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SuturTek Incorporated 510(k) Premarket Notification FASTCLOSE™ Sternum Closure Device

K032Y68

510(k) Number (if known):

FASTCLOSE Sternum Closure Device Device Name:

Indications For Use:

(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 _________________________________________________________________________________________________________________________________________________________

Miriam C. Provoost

Division of General, Restorative and Neurological Device

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510(k) Number K032468

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.