(85 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a silicone tendon spacer, with no mention of AI or ML technologies.
Yes
This device is used for temporary implantation in tendon reconstruction surgery to facilitate healing and tissue preparation before a permanent tendon autograft is placed. This aligns with the definition of a therapeutic device as it is used to treat a medical condition.
No
The device is a temporary implant used in a two-step tendon reconstruction surgery to create a pseudo-sheath, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of silicone elastomer, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a temporary implant used in surgical procedures to facilitate tendon reconstruction. It is placed within the body to create a pseudo-sheath for a later tendon graft.
- Lack of Testing: The device does not perform any tests on biological samples. Its function is purely mechanical and structural within the surgical context.
Therefore, based on the provided information, the Single Size Tendon Spacer is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Surgical indications for the Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 6 months.
Product codes (comma separated list FDA assigned to the subject device)
HXA
Device Description
The Single Size Tendon Spacer is designed to facilitate the two-step tendon reconstruction surgery. The device is 50 cm long, and its oval cross section increases progressively over its length from 3.0 x 1.5 mm to 3.0 mm. The spacer slope is designed to match shapes and dimensions of the digital canal. The spacers are made of high performance medical grade silicone elastomer containing barium suffate to provide radio-opacity. During the first stage of the reconstruction surger is placed into the reconstructed tendon bed and slid until optimum fit is achieved. The tendon is attached to the distal phalanx and the proximal spacer end is left free in the palm or forelimb. Excess spacer material is cut off. The second stage of surgery is performed 2 to 6 months later, once an appropriate pseudo-sheath has been created around the spacer, and tissues are soft and pliable. The spacer is then removed and replaced by a permanent active tendon autograft. The device is not intended as permanent implant or to function as a replacement for a ligament or tendon.
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)
Studies demonstrated that the Single Size Tendon Spacer devices have the equivalent mechanical strength and biocompatibility performances to the predicate device.
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.
Wright Medical Technology Swanson Tendon Spacer
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
§ 888.3025 Passive tendon prosthesis.
(a)
Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, surrounded by a circle of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medist International Bernard F. Grisoni, Ph.D. 9160 Highway 64 Suite 12 Lakeland, Tennessee 38002 July 26, 2017
Re: K000019
Trade/Device Name: Single Size Tendon Spacer Regulation Number: 21 CFR 888.3025 Regulation Name: Passive tendon prosthesis Regulatory Class: Class II Product Code: HXA Dated: January 3, 2000 Received: January 4, 2000
Dear Dr. Grisoni:
This letter corrects our substantially equivalent letter of March 29, 2000.
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: 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
1
Page 2 - Bernard Grisoni, Ph.D.
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.
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.
Mark N. Melkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KOODO19 510(k) Number:
Device Name: Single Size Tendon Spacer
Indication For Use:
Surgical indications for the Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 6 months.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ume R. bochner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _KOOOC/ 19
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
3
MAR 2 9 2000
.. . .. -..
K 0000019 Medist International
9160 Highway 64, Suite 12 Lakeland, TN 38002 Phone: (901) 380-9411 Fax: (901) 389-8412
510(K) SUMMARY
(As required by section 21 CFR 807.92(c))
| Submitter's name: | Medist International |
|---|---|
| Submitter's address: | 9160 Highway 64, Suite 12, Lakeland, TN 38002 |
| Submitter's telephone number: | (901) 380-9411 |
| Contact Person: | Bernard F. Grisoni |
| Submission date: | January 3, 2000 |
| Trade Name: | Single size Tendon Spacer (name subject to change) |
| Common Name: | Tendon Spacer |
| Classification Name: | Prosthesis, Tendon, Passive |
Legally marketed predicate devices: Wright Medical Technology Swanson Tendon Spacer
Device description:
The Single Size Tendon Spacer is designed to facilitate the two-step tendon reconstruction surgery. The device is 50 cm long, and its oval cross section increases progressively over its length from 3.0 x 1.5 mm to 3.0 mm. The spacer slope is designed to match shapes and dimensions of the digital canal. The spacers are made of high performance medical grade silicone elastomer containing barium suffate to provide radio-opacity. During the first stage of the reconstruction surger is placed into the reconstructed tendon bed and slid until optimum fit is achieved. The tendon is attached to the distal phalanx and the proximal spacer end is left free in the palm or forelimb. Excess spacer material is cut off. The second stage of surgery is performed 2 to 6 months later, once an appropriate pseudo-sheath has been created around the spacer, and tissues are soft and pliable. The spacer is then removed and replaced by a permanent active tendon autograft. The device is not intended as permanent implant or to function as a replacement for a ligament or tendon.
Indication for use:
Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon.
Technological characteristics:
The Single Size Tendon Spacer device has the equivalent technological characteristics (i.e. chemical composition, and mechanical strength) to the predicate device.
Performance data:
Studies demonstrated that the Single Size Tendon Spacer devices have the equivalent mechanical strength and biocompatibility performances to the predicate device.
Basis for substantial equivalence:
The Single Size Tendon Spacer device is safe and effective because they are equivalent to the predicate devices in terms of chemical composition, indication of use, and product performances.