SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17

K063603 · Suturtek Incorporated · GAQ · Feb 7, 2007 · General, Plastic Surgery

Device Facts

Record IDK063603
Device NameSUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
ApplicantSuturtek Incorporated
Product CodeGAQ · General, Plastic Surgery
Decision DateFeb 7, 2007
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 878.4495
Device ClassClass 2
AttributesTherapeutic

Intended Use

The SuturTek Surgical Steel Suture is intended for use in sternal closure.

Device Story

SuturTek Surgical Steel Suture is a sterile, single-use, non-absorbable, stainless steel monofilament suture. Used during thoracic surgery for sternal closure; device remains inside patient post-procedure. May be attached to stainless steel needle. Manual instrument used by surgeon to pass needle through sternum for fixation. Provides mechanical stabilization of sternum. Disposables include needle and unused suture portions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel monofilament suture; non-absorbable; sterile; single-use. Manual operation. No electronic components or software.

Indications for Use

Indicated for sternal closure following thoracic surgery (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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 63603 1/2 ## 510(k) Summary of Safety and Effectiveness SuturTek Surgical Steel Suture December 1, 2006 FEB 7 2007 - 1. Sponsor Name Sponsor/Manufacturer: SuturTek Incorporated 51 Middlesex Street North Chelmsford, Massachusetts 01863 Telephone: 978-251-8088 FAX: 978-251-8585 - 2. Contact person: A. Arthur Rankis 508 847-5961 - 3. Device Name Proprietary Name: SuturTek Surgical Steel Suture Common/Usual Name: Surgical Suture, Nonabsorbable, Stainless Steel. Panel: General and Plastic Surgery Devices Panel Product Code: GAQ 878.4495 - Suture, Nonabsorbable, Steel, Monofilament And Multifilament - 4. Identification of Predicate or Legally Marketed Devices Aesculap: Steelex Sternum Set; K023411 CP Medical: Surgical Steel Monofilament Stainless Steel; K030351 ## 5. Device Description The SuturTek Surgical Steel Suture is for use during thoracic surgery to hold and close the sternum after a sternotomy (i.e. for use in sternal closure). The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables. - Intended Use 6. The SuturTek Surgical Steel Suture is intended for use in sternal closure. {1}------------------------------------------------ - Comparison of Technological Characteristics 7. The SuturTek Surgical Steel Suture is substantially equivalent in its intended use and/or function to the following predicate devices: Aesculap: Steelex Sternum Set; K023411 CP Medical: Surgical Steel Monofilament Stainless Steel; K030351 The operating principle, materials, intended use and design of construction of the SuturTek Surgical Steel Suture 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. ## 8. Performance Testing Bench testing was performed to demonstrate that the SuturTek Surgical Steel Suture would perform as intended. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SuturTek Incorporated % A. A. Rankis & Associates Mr. A. Arthur Rankis President 6 Brookside Circle Acton, Massachusetts 01720 FEB 7 2007 Re: K063603 Trade/Device Name: SuturTek Surgical Steel Suture Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: December 1, 2006 Received: December 5, 2006 Dear Mr. Rankis: 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 {3}------------------------------------------------ Page 2 - Mr. A. Arthur Rankis 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. -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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html . Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ SuturTek Incorporated 510(k) Premarket Notification SuturTek Surgical Steel Suture િન્વ ભડ્તાના નિર્માન કારણે તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 510(k) Number (if known): K063603 Device Name: SuturTek Surgical Steel Suture Indications For Use: The SuturTek Surgical Steel Suture is intended for use in sternal closure. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of &DRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division of General, Restorative, and Neurological Devices 510(k) Number K062603 Page 1 of
Innolitics
510(k) Summary
Decision Summary
Classification Order
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