SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE

K082828 · Suturtek Incorporated · GAQ · Oct 14, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082828
• Device Name: SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
• Applicant: Suturtek Incorporated
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Oct 14, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SuturTek 360° Sternal 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

SuturTek 360° Sternal Closure Device is a surgical instrument used to pass stainless steel needles through the sternum for fixation with stainless steel sutures. The device features a cartridge-loaded needle and suture system; an internal drive mechanism engages and drives the needle through the sternum. The device is used by surgeons during thoracic surgery following a sternotomy. By automating the needle-passing process, the device aids in the prevention of suture needlestick injuries. After the suture is passed, the device is withdrawn, leaving the suture loop in place for manual tying. The device is sterilized prior to use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Instrument for sternal closure; utilizes stainless steel needles and sutures. Features an internal mechanical drive system for needle advancement. Device is provided sterilized. Manual operation.

Indications for Use

Indicated for use during thoracic surgery to hold and close the sternum after a sternotomy in patients undergoing such procedures.

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™ Sternum Closure Device™ (K032468)

Submission Summary (Full Text)

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OCT 1 4 2008

## 510(k) Summary of Safety and Effectiveness SuturTek 360° Sternal Closure Device™

#### l. Sponsor/Manufacturer Name:

SuturTek Incorporated 51 Middlesex Street North Chelmsford, Massachusetts 01863 Telephone: [phone] Fax: [phone]

### Contact:

Mr. Arthur Rankis A. A. Rankis & Associates, Inc. 6 Brookside Circle Acton, MA 01720 508 847 5961 [e-mail]

- 2. Device Name

| Proprietary Name: | SuturTek 360° Sternal Closure Device™ |
|--------------------|------------------------------------------------------------------------------------|
| Common/Usual Name: | (Classification Name) Suture, Nonabsorbable, Steel, Monofilament And Multifilament |
| Panel: | General Surgery |
| Product Code: | GAQ |
| 878.4495 | Suture, Nonabsorbable, Steel, Monofilament and Multifilament |

- 3. Identification of Predicate or Legally Marketed Device SuturTek FASTCLOSE™ Sternum Closure Device™ K032468

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#### 4. Device Description and Operation

The SuturTek 360° Sternal Closure Device™ is a an instrument that is used to pass stainless steel needles through sternum for fixation with stainless steel sutures. It is used to hold and close the sternum after a sternotomy ::

The device is sterilized before each use. 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 tissue. 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 placed in the same manner and then the ends of the suture are tied together in the usual fashion.

#### న్ Intended Use

The SuturTek 360° Sternal 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.

#### 6. Substantial Equivalence

Documentation was provided which demonstrated that the SuturTek 360° Sternal Closure Device™ is substantially equivalent to the predicate device, the SuturTek FASTCLOSE™ Sternum Closure Device™ K032468

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in a simple, black silhouette. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

ULI 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SuturTek Inc. % A. A. Rankis & Associates. Inc. Mr. Arthur Rankis President 6 Brookside Circle Acton, Massachusetts 01720

Rc: K082828

Trade/Devicc Name: SuturTek 360 Sternal Closure Device™ Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAO Dated: September 23, 2008 Received: September 25, 2008

Dear Mr. Rankis:

We have reviewed your Scction 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

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Page 2 - Mr. Arthur Rankis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Postmarket 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 vours.

Mark N. Milkeran

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):_ KQ82828

Device Name: Suturtek 360° Sternal Closure Device

Indications For Use:

The Suturtek 360° Sternal 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 needle stick injuries.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
|-------------------------------------------------|---|--------|------------------------------------------------|--|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | K082828 |
|---------------|---------|
|---------------|---------|