FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP

K140127 · Pontis Orthopaedics, LLC · GAQ · May 28, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140127
• Device Name: FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
• Applicant: Pontis Orthopaedics, LLC
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: May 28, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ferroFIBRE™ Stainless Steel Suture are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.

Device Story

ferroFIBRE™ with Crimp is a nonabsorbable sterile surgical suture composed of stainless steel; available in USP sizes 4-0 to #3; attached to stainless steel needles. Device includes stainless steel crimps as an alternative to knot tying for securing suture strands. Used in clinical settings by surgeons for soft tissue approximation, abdominal wound closure, hernia repair, sternal closure, and orthopaedic procedures (cerclage/tendon repair). Crimp size varies based on suture size and number of strands (4 or 8). Device is single-use and implantable. Benefits include secure fixation of tissue without traditional knot tying.

Clinical Evidence

Bench testing only. Verification and validation included knot failure force, crimp failure force, and cyclic loading tests. Biocompatibility data from predicate submissions K101126 and K081060 remain applicable.

Technological Characteristics

Stainless steel suture; stainless steel crimps; single-use; sterile; ethylene oxide sterilization. Suture sizes 4-0 to #3. Crimp size dependent on suture size and strand count (4 or 8).

Indications for Use

Indicated for soft tissue approximation, abdominal wound closure, hernia repair, sternal closure, and orthopaedic procedures including cerclage and tendon repair in patients requiring surgical suture fixation.

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

• ferroFibre™ (K081060)
• PONTIS™ Sutures and Suture Anchor with Crimps (K101126)

Submission Summary (Full Text)

{0}------------------------------------------------

ATTACHMENT 8

K140127 pg.l of 2

PONTIS

Tat

ORTHOPAEDICS

510(k) Summary

| Owner's Name | Leonard Gordon |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address | 2299 Post Street Suite 107<br>San Francisco, CA 94115 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| 510(k) Owner | PONTIS Orthopaedics, LLC |
| Contact Person | Leonard Gordon |
| Date Prepared | April 22, 2014 |
| Trade Name | ferroFIBRE™ with Crimp |
| Common name | Stainless Steel Suture |
| Classification Name | Stainless Steel Suture |
| Section | §C.F.R. Section 878.4495 |
| Product Code | GAQ |
| Predicate Device(s) | ferroFibre™ (K081060)<br>PONTIS™ Sutures and Suture Anchor with Crimps (K101126) |
| Device Description | The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture<br>with a crimp composed of stainless steel. The ferroFibre™ with Crimp<br>is available in USP sizes 4-0 to size 3, attached to stainless steel<br>needles of various types and sizes. The ferroFibre™ suture was<br>previously cleared in the K081060. A stainless steel crimp is being<br>added to provide an alternate to knot tying. The use of the crimp for<br>size 3-0 and 4-0 was cleared under submission K101126. |
| Reason for 510(k) | Device Modification - To allow the use of a crimp for securing size 3-<br>0 to #3 ferroFibre™ cleared under K081060 as an alternate to knot<br>tying. |
| Indications for Use | ferroFibre™ Stainless Steel Suture with Crimp is intended for use in<br>soft tissue approximation and for use in abdominal wound closure.<br>hernia repair, sternal closure and certain orthopaedic procedures<br>including cerclage and tendon repair |

{1}------------------------------------------------

| Technological<br>Characteristics | The ferroFIBRE stainless steel suture is the same suture as was cleared under K081060. This submission includes the same crimp tool for 2-0, 3-0 and 4-0 as was cleared in K101126. A larger crimp tool will be used with the ferroFibreTM stainless steel sutures from 0 to size 3. The indications for use are the same as K081060.<br><br>As for the crimps, each suture size and number of suture strands, 4 or 8, will require a different crimp size.<br><br>All biocompatibility testing performed, which was conducted under the predicate submissions K101126 and K081060 remain applicable for this submission as the materials are the same. This indicates that the components are safe for their intended use.<br><br>The PONTIS ferroFibre with Crimps is a single use, sterile implantable device, sterilized by ethylene oxide. The predicate devices are single use, sterile implantable device, sterilized by gamma irradiation and by ethylene oxide. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The PONTIS ferroFibre with Crimps are substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicates ferroFibre and Pontis Suture and Suture Anchors with Crimps. The risk analysis performed, raised no new issues of safety or effectiveness.<br><br>The use of the crimp was cleared under the Pontis submission K101126, for size 3-0 to and 4-0 ferroFibreTM. This submission expands the use of a crimp with the ferroFibreTM suture for the indications cleared under K081060. |
| Nonclinical Tests<br>Performed | The verification and validation testing of the Pontis ferroFibre with Crimps includes knot failure force, crimp failure force and cyclic loading. |
| Conclusions Drawn | Non-clinical tests conducted demonstrates that the proposed device is safe, effective, and performs as well as the predicate devices, therefore demonstrating substantial equivalence. |

and the state of the same

.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Flampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2014

PONTiS Orthopacdics. LILC Mr. Leonard Gordon President 2299 Post Street San Francisco. California 94115

Re: K140127

Trade/Device Name: ferroFIBRE Stainless Steel Suture with Crimp Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAQ Dated: April 22, 2014 Received: April 28, 2014

Dear Mr. Gordon.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Leonard Gordon

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Statement of Indications for Use

510 (K) Number (if Known): K140127

Manufacturer: PONTiS Orthopaedics, LLC

Device Name; ferroFIBRE™ Stainless Steel Suture with Crimp

ferroFIBRE™ Stainless Steel Suture are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.

Prescription Use XX (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Exemption (ODE)

Peter L. Hudson -S