(29 days)
Not Found
No
The summary describes a mechanical implant and delivery system, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an implantable suture retention device used for soft tissue repairs, not for treating or curing a disease or condition. Its purpose is mechanical support rather than therapeutic action.
No
Explanation: The device description states that the Arthrex SpeedCinch is an implantable suture retention device used for soft tissue repairs, specifically meniscal tears. This indicates it is a therapeutic or repair device, not a diagnostic one.
No
The device description explicitly states it consists of implants and an implant delivery mechanism, which are physical hardware components.
Based on the provided information, the Arthrex SpeedCinch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears." This describes a surgical device used in vivo (within the body) for repair.
- Device Description: The description details implants made of PEEK and FiberWire, and a handheld surgical instrument for delivery. This aligns with a surgical implant and delivery system, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arthrex SpeedCinch does not fit this description.
N/A
Intended Use / Indications for Use
The Arthrex SpeedCinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Product codes
MBI, GAT
Device Description
The Arthrex SpeedCinch is an implantable suture retention device which consists of implants and an implant delivery mechanism. The implants are composed of PEEK Optima® (polyetheretherketone) anchors and FiberWire (Polyethylene/Polyester) suture offered in #2-0 size. The implant delivery mechanism is a handheld manual surgical instrument with trigger for implant delivery.
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
Mechanical testing data demonstrates that the tensile strength (pull out strength) and cyclic displacement of the proposed Arthrex SpeedCinch device are substantially equivalent to or better than the tensile strength and cyclic displacement of the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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:
2.1510(K) SUMMARY
K132043 Page 1/2
・
| Date Summary Prepared | July 30, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Leon Brown II, Ph.D. |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 2028 | |
| Fax: 239/598.5508 | |
| Email: Leon.Brown@Arthrex.com | |
| Trade Name | Arthrex SpeedCinch |
| Common Name | Fastener, fixation, nondegradable soft tissue |
| Product Code -Classification Name | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| GAT - Suture, Nonabsorbable, Synthetic, Polyethylene | |
| CFR | 21 CFR 878.5000: Nonabsorbable poly(ethylene |
| terephthalate) surgical suture | |
| 21 CFR 888.3040: Smooth or threaded metallic bone | |
| fixation fastener | |
| Predicate Device | K073149: Arthrex Meniscal Cinch |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain clearance for the Arthrex SpeedCinch. | |
| Device Description | The Arthrex SpeedCinch is an implantable suture |
| retention device which consists of implants and an | |
| implant delivery mechanism. The implants are composed | |
| of PEEK Optima® (polyetheretherketone) anchors and | |
| FiberWire (Polyethylene/Polyester) suture offered in #2-0 | |
| size. The implant delivery mechanism is a handheld | |
| manual surgical instrument with trigger for implant | |
| delivery. | |
| Intended Use | The Arthrex SpeedCinch is an implantable suture |
| retention device which facilitates percutaneous or | |
| endoscopic soft tissue repairs, including the repair of | |
| meniscal tears. | |
| Substantial Equivalence Summary | Based on the intended use, technological characteristics |
| and comparison to the predicate device, Arthrex, Inc. has | |
| determined that the proposed Arthrex SpeedCinch is | |
| substantially equivalent to the currently marketed | |
| predicate device, Arthrex Meniscal Cinch (K073149). | |
| The Arthrex SpeedCinch is an implantable suture | |
| retention device which consists of implants and an | |
| implant delivery mechanism. The proposed device | |
| implant has a smaller diameter than the predicate device | |
| for lower profile anchoring. Mechanical testing data | |
| demonstrates that the tensile strength (pull out strength) | |
| and cyclic displacement of the proposed Arthrex | |
| SpeedCinch device are substantially equivalent to or | |
| better than the tensile strength and cyclic displacement | |
| of the predicate device. The implant materials and | |
| general function of the implant are the same as the | |
| predicate device. | |
| The implant delivery mechanism of the proposed device | |
| has been modified for ascetics and to move the implant | |
| delivery trigger from being a thumb trigger to being a | |
| forefinger trigger for ergonomic ease of use. A nose | |
| cover depth stop was added. A downward slant nose | |
| option was added to accommodate physician preference. | |
| Any differences between the Arthrex SpeedCinch and the | |
| predicate are considered minor and do not raise | |
| questions concerning safety and effectiveness. |
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K132043 Page 2/2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans. The eagle is stylized and abstract, with flowing lines representing its feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Mr. Leon Brown II, Ph.D. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
July 31, 2013
Rc: K132043
Trade/Device Name: Arthrex SpeedCinch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, MBI Dated: July 9, 2013 Received: July 17, 2013
Dear Mr. Brown:
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 10 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 docs 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 cither 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. Leon Brown II, Ph.D.
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
" Enclosure
4
2.5 INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): '
Device Name:
Arthrex SpeedCinch
Indications For Use:
The Arthrex SpeedCinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Prescription Use _ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132043