(26 days)
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Not Found
No
The device description and performance studies focus on mechanical instrumentation for surgical procedures, with no mention of AI or ML technologies.
No.
The device description clearly states it is "Orthopedic surgical instruments designed for osteochondral implants" intended to "manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants." These are tools used during a therapeutic procedure, but are not themselves therapeutic devices (which would typically deliver treatment or therapy).
No
The device description indicates it is "Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation... intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants." This describes tools used during surgery, not a device that diagnoses conditions.
No
The device description explicitly states it is "Orthopedic surgical instruments" and describes physical manipulation of bone and cartilage tissue, indicating a hardware device. The performance studies also focus on biocompatibility, reprocessing, and functional testing of physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc." This describes a surgical procedure involving the placement of an implant within the body.
- Device Description: The description details "Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation." These are tools used during surgery to manipulate tissue and the implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples.
- Predicate Device: The predicate device is "Cartiva SCI Instrumentation (Product Code QBO, Regulation Number 21 CFR 888.4505)". This regulation number (21 CFR 888.4505) falls under the category of "Orthopedic devices," specifically "Osteochondral allograft." This further confirms its classification as a surgical device, not an IVD.
In summary, the device is clearly described as surgical instrumentation used in an orthopedic procedure, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
Product codes
QBO
Device Description
Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Cartiva Reusable Instrumentation set was carried out, including:
Biocompatibility per ISO 10993-1
Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-10)
Reprocessing:
Cleaning validation:
Cleaning validation per AAMI TIR30 and AAMI TIR12 Sterilization Validation
Sterilization validation per AAMI TIR39, ISO 17665-1 and ANSI/AAMI ST79
Performance/Functional Testing Ship studies per ASTM D4169 Simulated Use Testing in beyond use conditions to demonstrate functionality
All data demonstrated that the safety and performance of the Cartiva SCI Reusable Instrumentation is not affected by the proposed modification to add two additional sizes, 6mm and 12mm, to the Cartiva existing reusable instrumentation product line.
A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are all preserved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cartiva SCI Instrumentation (Product Code QBO, Regulation Number 21 CFR 888.4505)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
(a)
Identification. Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cartiva, Inc. Shriya Kafle Regulatory Specialist 6120 Windward Parkway, Suite 220 Alpharetta, Georgia 30005
Re: K192156
Trade/Device Name: Cartiva® SCI Reusable Instrumentation Set Regulation Number: 21 CFR 888.4505 Regulation Name: Orthopedic surgical instrumentation designed for osteochondral implants with pressfit fixation Regulatory Class: Class II Product Code: QBO Dated: August 8, 2019 Received: August 9, 2019
Dear Shriya Kafle:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192156
Device Name Cartiva® SCI Reusable Instrumentation Set
Indications for Use (Describe)
Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
| 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.
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3
Image /page/3/Picture/0 description: The image shows the word "CARTIVA" in large, green letters. Below that, in smaller, blue letters, are the words "Synthetic Cartilage Implant". The background is a dark blue color.
WRIGHT.
K192156 Page 1 of 2
510(k) Number: K192156 Date Submitted: August 9, 2019
510(k) Summary
SUBMITTER'S INFORMATION
| Owner: | Cartiva, Inc. |
|---|---|
| Address: | 6120 Windward Parkway, Suite 220, Alpharetta, GA 30005 |
| Phone: | 770-754-3817 |
| Fax Numbers: | 770-754-3808 |
| Contact Person: | Shriya Kafle, Regulatory Specialist |
DEVICE INFORMATION
| Name of Device: | Cartiva SCI Reusable Instrumentation Set |
|---|---|
| Common/Usual Name: | Orthopedic Surgical Instrumentation |
| Classification Name: | Orthopedic Surgical Instrumentation designed for osteochondral |
| implants with press-fit fixation (Product Code QBO) | |
| Predicate Device(s): | Cartiva SCI Instrumentation (Product Code QBO, Regulation |
| Number 21 CFR 888.4505) | |
| Device Description: | Orthopedic surgical instruments designed for osteochondral |
| implants with press-fit fixation are devices intended to | |
| manipulate bone and cartilage tissue or the implant for the | |
| positioning, alignment, defect creation, and placement of press- | |
| fit osteochondral implants that utilize no additional means of | |
| fixation (e.g., suture fixation, adhesives). This type of device | |
| includes instruments specific to the geometry of the implant. | |
| Indication for Use: | Orthopedic surgical instrumentation supplied by Cartiva, Inc. is |
| indicated for use in the press-fit fixation of the implantable | |
| medical device products manufactured by Cartiva, Inc | |
| Technological | |
| Characteristics: | The line extension of Cartiva SCI Reusable Instrumentation to |
| add two additional sizes (6mm and 12mm) to the existing | |
| reusable instrumentation product line do not raise new questions | |
| of safety or effectiveness. All technological aspects of press-fit | |
| fixation are preserved. | |
| Comparison to Predicate | |
| Device: | |
| , Suite 220 | The Cartiva SCI Reusable Instrumentation set use and |
| performance characteristics are not altered by this modification | |
| to add two additional sizes, (6mm and 12mm) to the existing | |
| Cartiva reusable instrumentation product line. | |
| Performance Data: | Testing of the Cartiva Reusable Instrumentation set was carried out, including: |
| Biocompatibility per ISO 10993-1 | |
| Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-10) | |
| Reprocessing: | |
| Cleaning validation: | |
| Cleaning validation per AAMI TIR30 and AAMI TIR12 Sterilization Validation | |
| Sterilization validation per AAMI TIR39, ISO 17665-1 and ANSI/AAMI ST79 | |
| Performance/Functional Testing Ship studies per ASTM D4169 Simulated Use Testing in beyond use conditions to demonstrate functionality | |
| All data demonstrated that the safety and performance of the Cartiva SCI Reusable Instrumentation is not affected by the proposed modification to add two additional sizes, 6mm and 12mm, to the Cartiva existing reusable instrumentation product line. | |
| A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are all preserved. | |
| Rationale for Substantial Equivalence: | This modification falls within the FDA regulations for 510(k) review. The indication for use, intended use, principles of operation, and performance have not been altered. The minor change to add the new Cartiva SCI Reusable Instrumentation sizes 6mm and 12mm to the existing Cartiva Reusable Instrumentation portfolio (8mm and 10mm) do not raise any new questions of safety or effectiveness. The new Cartiva SCI Reusable Instrumentation sizes 6mm and 12mm have demonstrated to provide the same level of performance as the predicate device, Cartiva SCI Instrumentation, (Product Code QBO, Regulation Number 21 CFR 888.4505). Therefore, the new Cartiva SCI Reusable Instrumentation Set (6mm and 12mm) is substantially equivalent to the predicate Cartiva SCI Instrumentation, (Product Code QBO, Regulation Number 21 CFR 888.4505). |
| Conclusion: | The Cartiva SCI Reusable Instrumentation, as modified by this 510(k), do not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale. |
Wright Medical Group N 6120 Windward Parkway Alpharetta, GA 30005 877.336.4616
cartiva.net | wright.com
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Image /page/4/Picture/0 description: The image shows the logo for "Cartiva Synthetic Cartilage Implant". The word "Cartiva" is in a large, light green font. Below that, the words "Synthetic Cartilage Implant" are in a smaller, white font.
TT WRIGHT.
K192156 Page 2 of 2
Wright Medical Group N.V.
6120 Windward Parkway, Suite 220
Alpharetta, GA 30005 877.336.4616
cartiva.net | wright.com