(146 days)
No
The 510(k) summary describes a simple suture construct and delivery device for soft tissue approximation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are based on material properties (tensile strength, diameter) and endotoxin testing, not algorithmic performance.
Yes
The device is a suture construct used for soft tissue approximation in orthopedic procedures, which is a therapeutic application.
No
The device is a suture construct and delivery system used for soft tissue approximation in orthopedic procedures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a "suture construct provided on a disposable delivery device," indicating physical components beyond software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation in orthopedic procedures." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from a patient (which is the definition of an IVD).
- Device Description: The device is a "suture construct provided on a disposable delivery device." This is a surgical tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The device is clearly a surgical implant/tool used for repairing soft tissue during orthopedic surgery.
N/A
Intended Use / Indications for Use
The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.
Product codes
GAT
Device Description
The SPEEDTRAP graft preparation system consists of a suture construct provided on a disposable delivery device. The SPEEDTRAP Graft Preparation system is offered in long and short configurations with white (undyed) and green/white (undyed) color options, including single and multi-pack (Qty. 4) offerings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 determination of substantial equivalence for this device was based on a detailed device description, performance data equivalence, and conformance to consensus and voluntary standards. Performance data equivalence was established using non-clinical testing, including suture diameter and suture tensile strength testing. The proposed SPEEDTRAP suture construct is comprised of the same materials and is similar in design to the predicate Size 2 ORTHOCORD (K040004; K043298) and ETHIBOND EXCEL (K946173), sutures. The proposed SPEEDTRAP suture construct also met requirements of bacterial endotoxin testing. Based on the similarities of the intended use, materials, technological characteristics, and performance comparison to predicate devices, the SPEEDTRAP graft preparation system has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads in profile, facing right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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 (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" (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 (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 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)
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
Preparation
| Date | September 29, 2016 |
|---|---|
| Submitter's | |
| Name and | |
| Address | DePuy Mitek |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person | Jeffrey Dzialo |
| Regulatory Affairs Specialist | |
| DePuy Mitek | |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767, USA | |
| Telephone: 508-977-3998 | |
| Facsimile: 508-977-6911 | |
| e-mail: JDzialo@its.jnj.com | |
| Name of | |
| Medical Device | Proprietary Name: SPEEDTRAP™ Graft Preparation System |
| Classification Name: Polyethylene, suture, nonabsorbable, synthetic, | |
| Common Name: Suture | |
| Substantial | |
| Equivalence | |
| Predicate | |
| Devices | The SPEEDTRAP™ Graft Preparation System is substantially equivalent to, |
| Primary Predicate: | |
| K040004: ORTHOCORD® Suture (USP Size 2, Violet) (April 13, 2004) | |
| Reference predicates: | |
| K043298: ORTHOCORD® Suture (USP Size 2, Blue) (Dec 10, 2004) | |
| K946173: ETHIBOND EXCEL Suture (USP Size 2, Green) (January 09, 1995) | |
| Device | |
| Classification | Class II: |
| Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture, | |
| product code GAT. | |
| Device | |
| Description | The SPEEDTRAP graft preparation system consists of a suture construct provided on |
| a disposable delivery device. | |
| The SPEEDTRAP Graft Preparation system is offered in long and short configurations | |
| with white (undyed) and green/white (undyed) color options, including single and | |
| multi-pack (Qty. 4) offerings. | |
| Indications for | |
| Use | The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in |
| orthopedic procedures. | |
| Safety and | |
| Performance | The determination of substantial equivalence for this device was based on a detailed |
| device description, performance data equivalence, and conformance to consensus and | |
| voluntary standards. Performance data equivalence was established using non-clinical | |
| testing, including suture diameter and suture tensile strength testing. | |
| The proposed SPEEDTRAP suture construct is comprised of the same materials and is | |
| similar in design to the predicate Size 2 ORTHOCORD (K040004; K043298) and | |
| ETHIBOND EXCEL (K946173), sutures. The proposed SPEEDTRAP suture | |
| construct also met requirements of bacterial endotoxin testing. | |
| Based on the similarities of the intended use, materials, technological characteristics, | |
| and performance comparison to predicate devices, the SPEEDTRAP graft preparation | |
| system has been shown to be substantially equivalent to predicate devices under the | |
| Federal Food, Drug and Cosmetic Act. |
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