(19 days)
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.
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 Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum.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.
The provided document is a 510(k) Summary of Safety and Effectiveness for the SuturTek 360° Sternal Closure Device™. This submission process seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a standalone study with ground truth establishment and expert adjudication.
Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of device performance evaluation.
Instead, the submission relied on demonstrating equivalence to the predicate device, the SuturTek FASTCLOSE™ Sternum Closure Device™ (K032468).
The document states:
- "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"
This type of submission focuses on comparing the new device's design, materials, and intended use to a device already cleared by the FDA, rather than conducting a de novo study to establish performance metrics against a defined standard.
{0}------------------------------------------------
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: 978-251-8088 Fax: 978-251-8585
Contact:
Mr. Arthur Rankis A. A. Rankis & Associates, Inc. 6 Brookside Circle Acton, MA 01720 508 847 5961 arankis@aarankis.com
-
- 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 |
-
- Identification of Predicate or Legally Marketed Device SuturTek FASTCLOSE™ Sternum Closure Device™ K032468
{1}------------------------------------------------
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
{2}------------------------------------------------
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
{3}------------------------------------------------
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 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
{4}------------------------------------------------
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(Part 21 CFR 801 Subpart D) | X | 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 CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K082828 |
|---|---|
| --------------- | --------- |
§ 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.