K Number
K140127
Device Name
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
Date Cleared
2014-05-28

(132 days)

Product Code
Regulation Number
878.4495
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ferroFIBRE™ Stainless Steel Suture with Crimp is 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 Description
The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture with a crimp composed of stainless steel. The ferroFibre™ with Crimp is available in USP sizes 4-0 to size 3, attached to stainless steel needles of various types and sizes. The ferroFibre™ suture was previously cleared in the K081060. A stainless steel crimp is being added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K101126.
More Information

Not Found

No
The document describes a surgical suture and crimp, with no mention of AI or ML technology in its description, intended use, or performance studies.

No
The device is a surgical suture with a crimp, intended for use in approximating soft tissue and closing wounds/repairs. It is a surgical tool used during procedures, not a therapeutic device for treating a condition after the fact.

No
The device is a surgical suture used for tissue approximation and wound closure, which are therapeutic procedures, not diagnostic ones.

No

The device description clearly states it is a "nonabsorbable sterile surgical suture with a crimp composed of stainless steel," indicating it is a physical medical device, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "soft tissue approximation and for use in abdominal wound closure. hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair." These are all surgical procedures performed on the body, not tests performed on samples taken from the body.
  • Device Description: The description details a "nonabsorbable sterile surgical suture with a crimp composed of stainless steel." This is a physical implant/device used during surgery.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on laboratory analysis.

IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for physical repair within the body.

N/A

Intended Use / Indications for Use

ferroFibre™ Stainless Steel Suture with Crimp is 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.

Product codes (comma separated list FDA assigned to the subject device)

GAQ

Device Description

The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture with a crimp composed of stainless steel. The ferroFibre™ with Crimp is available in USP sizes 4-0 to size 3, attached to stainless steel needles of various types and sizes. The ferroFibre™ suture was previously cleared in the K081060. A stainless steel crimp is being added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K101126.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue, abdominal, sternal, orthopaedic (including cerclage and tendon)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The verification and validation testing of the Pontis ferroFibre with Crimps includes knot failure force, crimp failure force and cyclic loading. Non-clinical tests conducted demonstrates that the proposed device is safe, effective, and performs as well as the predicate devices, therefore demonstrating substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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ATTACHMENT 8

K140127 pg.l of 2

PONTIS

Tat

ORTHOPAEDICS

510(k) Summary

Owner's NameLeonard Gordon
Submitter Address2299 Post Street Suite 107
San Francisco, CA 94115
Phone Number(415) 567-8935
Fax Number(415) 567-8934
510(k) OwnerPONTIS Orthopaedics, LLC
Contact PersonLeonard Gordon
Date PreparedApril 22, 2014
Trade NameferroFIBRE™ with Crimp
Common nameStainless Steel Suture
Classification NameStainless Steel Suture
Section§C.F.R. Section 878.4495
Product CodeGAQ
Predicate Device(s)ferroFibre™ (K081060)
PONTIS™ Sutures and Suture Anchor with Crimps (K101126)
Device DescriptionThe ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture
with a crimp composed of stainless steel. The ferroFibre™ with Crimp
is available in USP sizes 4-0 to size 3, attached to stainless steel
needles of various types and sizes. The ferroFibre™ suture was
previously cleared in the K081060. A stainless steel crimp is being
added to provide an alternate to knot tying. The use of the crimp for
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-
0 to #3 ferroFibre™ cleared under K081060 as an alternate to knot
tying.
Indications for UseferroFibre™ Stainless Steel Suture with Crimp is 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

1

| Technological
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.

As for the crimps, each suture size and number of suture strands, 4 or 8, will require a different crimp size.

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.

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
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.

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
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

.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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