(266 days)
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a prosthesis intended to replace a joint, which falls under the category of a surgical implant rather than a therapeutic device.
No.
The device is an implantable prosthesis designed to replace a joint, not to diagnose a condition.
No
The device description clearly states it is a "double-stemmed, constrained, silicone prosthesis," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant for surgical treatment of conditions affecting the first metatarsophalangeal joint. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a silicone prosthesis designed to be implanted to replace a joint. This is a medical device used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, 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. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:
- Hallux limitus or hallux rigidus
- · Painful rheumatoid arthritis
- · Hallux abducto valgus associated with arthritis
- · Unstable or painful joint from previous surgery
Product codes
KWH
Device Description
The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsophalangeal joint
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)
Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering analysis was also performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing right, suggesting a sense of community and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
In2Bones USA, LLC % Ms. Louise Focht President ENMED International, Inc. P.O. Box 249 Del Mar. California 92014
Re: K153609
Trade/Device Name: RTS Flexible 1st MPJ Implant w/Grommets Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KWH Dated: August 8. 2016 Received: August 9, 2016
Dear Ms. Focht:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Device Name: RTS Flexible 1st MPJ Implant w/Grommets
Indications for Use (Describe)
The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:
- Hallux limitus or hallux rigidus
- · Painful rheumatoid arthritis
- · Hallux abducto valgus associated with arthritis
- · Unstable or painful joint from previous surgery
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary of Safety and Effectiveness
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
- I. Submitter
| Date Prepared: | September 8, 2016 |
|---|---|
| Device Submitter: | In2Bones USA, LLC |
| 6060 Poplar Avenue, Suite 380 | |
| Memphis, TN 38119 | |
| Phone: | 901-260-7931 |
| Contact Person: | Louise Focht |
II. Device
| Proprietary Name: | RTS Flexible 1st MPJ Implant w/Grommets |
|---|---|
| Common Name: | Flexible Great Toe Implant |
| Classification Name: | Prosthesis, Toe, Constrained Polymer |
| Regulatory Class: | 21 CFR 888.3720, Class II |
| Product Code: | 87 KWH |
III. Predicate Device
| Predicate Device: | Futura Biomedical, Flexible Great Toe Implant |
|---|---|
| K981194 |
IV. Device Description
The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
V. Intended Use and Indications for Use
The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of: Hallux limitus or hallux rigidus, Painful rheumatoid arthritis, Hallux abducto valgus associated with arthritis, Unstable or painful joint from previous surgery
Comparison of technological characteristics with the predicate device VI.
The RTS Flexible 1* MPJ Implant w/Grommets and the legally marketed predicate device have the same intended use and indications for use, similar dimensions, geometry and materials. The In2Bones device and the predicate are both available in four sizes. The stems of the devices are
4
fit into the intramedullary canals of the first metatarsal phalangeal joint. The devices are constrained and made of silicone elastomer. The devices also have proximal and distal grommets that may be used with the silicone implant.
VII. Performance Data
Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering analysis was also performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified
VIII. Conclusions
The RTS Flexible 1ª MPJ Implant w/Grommets when compared to the predicate have the same intended use and indications for use, technological characteristics, and principals of operation as the predicate device. Thus the RTS Flexible 1st MPJ Implant w/Grommets design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.