SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

K032468 · Suturtek Incorporated · GAQ · Sep 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032468
• Device Name: SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
• Applicant: Suturtek Incorporated
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

FASTCLOSE Sternum Closure Device is a manual surgical instrument used during thoracic surgery to facilitate sternal closure. The system comprises a reusable instrument, a single-use disposable cartridge, a single-use disposable needle, and stainless steel sutures. The clinician loads the cartridge onto the distal end of the instrument; the internal drive mechanism engages the needle and drives it through the sternum. The device passes the suture through the wound, leaving a loop in place upon withdrawal. The clinician then ties the suture ends manually. The device is designed to reduce the risk of accidental needlestick injuries to the surgical staff during the closure process.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instrument; stainless steel needles and sutures; reusable instrument body with disposable cartridge/needle components. No electronic or software components.

Indications for Use

Indicated for patients undergoing thoracic surgery requiring sternal closure following sternotomy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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SEP 2 3 2003

K032468 P1/2

FASTCLOSE™ Sternum Closure Device

## SuturTek Incorporated 510(k) Premarket Notification

1.

# 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: [phone] FAX: [phone]

## 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.

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.

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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 [phone]. 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 [phone] or [phone] 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:

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.

(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)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provoost

Division of General, Restorative and Neurological Device

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510(k) Number K032468