SPEEDTRAP Graft Preparation System

K161638 · Medos International SARL · GAT · Nov 7, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161638
• Device Name: SPEEDTRAP Graft Preparation System
• Applicant: Medos International SARL
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Nov 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.

Device Story

SPEEDTRAP Graft Preparation System consists of a suture construct provided on a disposable delivery device. Used in orthopedic procedures for soft tissue approximation. Operates as a mechanical suture construct; no electronic or software components. Provides surgeons with a pre-configured suture for graft preparation. Benefits include standardized delivery and handling of suture material during orthopedic surgery.

Clinical Evidence

Bench testing only. Performance data included suture diameter and tensile strength testing, and bacterial endotoxin testing.

Technological Characteristics

Nonabsorbable poly(ethylene terephthalate) surgical suture. Provided on a disposable delivery device. Offered in long and short configurations with undyed or green/white color options.

Indications for Use

Indicated for soft tissue approximation in orthopedic procedures.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). 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

• ORTHOCORD Suture (K040004)
• ORTHOCORD Suture (K043298)
• ETHIBOND EXCEL Suture (K946173)

Submission Summary (Full Text)

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

November 7, 2016

Medos International SARL % Mr. Jeffrey Dzialo Depuy Mitek, A Johnson And Johnson Company 325 Paramount Dr. Raynham, Massachusetts 02767

Re: K161638

Trade/Device Name: SPEEDTRAP Graft Preparation System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 4, 2016 Received: October 6, 2016

Dear Mr. Dzialo:

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. Please note: CDRH 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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" (21 CFR 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 Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K161638

Device Name

SPEEDTRAP Graft Preparation System

Indications for Use (Describe)

The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) SUMMARY SPEEDTRAP™ Graft Preparation System

| Summary<br>Preparation<br>Date | September 29, 2016 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Contact Person | Jeffrey Dzialo<br>Regulatory Affairs Specialist<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: SPEEDTRAP™ Graft Preparation System<br>Classification Name: Polyethylene, suture, nonabsorbable, synthetic,<br>Common Name: Suture |
| Substantial<br>Equivalence<br>Predicate<br>Devices | The SPEEDTRAP™ Graft Preparation System is substantially equivalent to,<br>Primary Predicate:<br>K040004: ORTHOCORD® Suture (USP Size 2, Violet) (April 13, 2004)<br>Reference predicates:<br>K043298: ORTHOCORD® Suture (USP Size 2, Blue) (Dec 10, 2004)<br>K946173: ETHIBOND EXCEL Suture (USP Size 2, Green) (January 09, 1995) |
| Device<br>Classification | Class II:<br>Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture,<br>product code GAT. |
| Device<br>Description | The SPEEDTRAP graft preparation system consists of a suture construct provided on<br>a disposable delivery device.<br>The SPEEDTRAP Graft Preparation system is offered in long and short configurations<br>with white (undyed) and green/white (undyed) color options, including single and<br>multi-pack (Qty. 4) offerings. |
| Indications for<br>Use | The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in<br>orthopedic procedures. |
| Safety and<br>Performance | The determination of substantial equivalence for this device was based on a detailed<br>device description, performance data equivalence, and conformance to consensus and<br>voluntary standards. Performance data equivalence was established using non-clinical<br>testing, including suture diameter and suture tensile strength testing.<br>The proposed SPEEDTRAP suture construct is comprised of the same materials and is<br>similar in design to the predicate Size 2 ORTHOCORD (K040004; K043298) and<br>ETHIBOND EXCEL (K946173), sutures. The proposed SPEEDTRAP suture<br>construct also met requirements of bacterial endotoxin testing.<br>Based on the similarities of the intended use, materials, technological characteristics,<br>and performance comparison to predicate devices, the SPEEDTRAP graft preparation<br>system has been shown to be substantially equivalent to predicate devices under the<br>Federal Food, Drug and Cosmetic Act. |

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