(27 days)
No K/DEN numbers found in the text.
P160050
No
The description focuses on manual surgical instruments and a physical measurement tool made of stainless steel, with no mention of software, algorithms, or data processing that would indicate AI/ML. The submission purpose is also related to modifying the sterilization tray.
No
The device is a measurement tool used to assess defect size, not to treat or modify a physiological function. It aids in determining if a patient meets the indications for a therapeutic device (the Annular Closure Device), but is not therapeutic itself.
Yes
The device aids in determining if a patient meets certain indications by assessing the defect size in the annulus fibrosus, which is a diagnostic purpose.
No
The device description explicitly states that the Defect Measurement Tool is a manual surgical instrument made from stainless steel, included in a kit with other manual instruments. This indicates it is a physical tool, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Intrinsic Therapeutics Defect Measurement Tool is a manual surgical instrument used to physically measure the size of a defect in the annulus fibrosus during a surgical procedure. It is used in vivo (within the body) to aid in determining eligibility for another surgical device (the Barricaid® Annular Closure Device).
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It is a physical measurement tool.
- Anatomical Site: The device is used directly on the annulus fibrosus, which is an anatomical structure within the body, not on a sample taken from the body.
Therefore, the function and application of this device clearly fall outside the scope of an in vitro diagnostic. It is a surgical instrument used for measurement during a procedure.
N/A
Intended Use / Indications for Use
The Intrinsic Therapeutics Defect Measurement Tool for the Barricaid® Annular Closure Device is intended to aid in determining if a patient meets the indications for the Barricaid® Annular Closure Device by assessing the defect size in the annulus fibrosus following limited discectory. This tool is indicated to only be used with the Intrinsic Therapeutics Barricaid® Annular Closure Device.
Product codes
OHG, QHG
Device Description
The Barricaid® Instrument kit contains a number of manual surgical instruments as well as the Defect Measurement Tool. This kit is provided with all of the instruments with a sterilization tray. The Defect Measurement Tool is intended to measure the annular defect to determine if a patient meets the indications for use for the Barricaid® Annular Closure Device. All instruments are made from stainless steel. This kit is intended to be used only with the Intrinsic Therapeutics Barricaid® Annular Closure Device (ACD).
The purpose of this submission is to modify and reduce the size of the sterilization tray used to contain the reusable instruments necessary to surgically implant or remove the Barricaid® Annular closure device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
annulus fibrosus
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)
Bench Testing
Scientific evaluation of sterilization validation and cleaning validation based on worst case. Scientific evaluation of shipping condition based on worst case and market history.
Clinical Testing
No new clinical testing was performed.
Biocompatibility
No new biocompatibility testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Defect Measurement Tool (Product Code QHG, Regulation 21 CFR 888.4510)
Reference Device(s)
Barricaid® Annular Closure Device (ACD) – P160050
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 16, 2020
Intrinsic Therapeutics, Inc. Regina Shih VP, Regulatory Affairs 30 Commerce Way Woburn, Massachusetts 01801
Re: K201676
Trade/Device Name: Barricaid® Instrument Tray Regulation Number: 21 CFR 888.4510 Regulation Name: Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant Regulatory Class: Class II Product Code: OHG Dated: June 19, 2020 Received: June 19, 2020
Dear Regina Shih:
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.
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
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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 medical devices and radiation-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,
Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201676
Device Name Barricaid® Instrument Kit
Indications for Use (Describe)
The Intrinsic Therapeutics Defect Measurement Tool for the Barricaid® Annular Closure Device is intended to aid in determining if a patient meets the indications for the Barricaid® Annular Closure Device by assessing the defect size in the annulus fibrosus following limited discectory. This tool is indicated to only be used with the Intrinsic Therapeutics Barricaid® Annular Closure Device.
| 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) |
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Image /page/3/Picture/0 description: The image contains the logo for Intrinsic Therapeutics. The logo consists of a blue circle with a stylized "I" inside, followed by the words "INTRINSIC" in blue and "THERAPEUTICS" in teal. The "I" in the circle is designed to look like a spine.
510(k) Summary (21 CFR 807.92)
K201676 Page 1 of 3
1. Submitter
| Submitter Name: | Intrinsic Therapeutics |
|---|---|
| Address: | 30 Commerce Way, Woburn, MA 01801 |
| Telephone: | 781-932-0222 |
| Contact Person: | Regina Shih |
| E-mail: | RShih@in-Thera.com |
| Date: | July 14, 2020 |
II. Device Information
Device Name: Barricaid® Instrument Kit Common Name: Defect measurement Tool Classification Panel: Orthopedic Regulation Number: 21 CFR 888.4510 Regulatory Class: 2 Product Code: QHG
III. Predicate Device
Primary Predicate: Defect Measurement Tool (Product Code QHG, Regulation 21 CFR 888.4510)
Reference Device: Barricaid® Annular Closure Device (ACD) – P160050
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IV. Device Description
The Barricaid® Instrument kit contains a number of manual surgical instruments as well as the Defect Measurement Tool. This kit is provided with all of the instruments with a sterilization tray. The Defect Measurement Tool is intended to measure the annular defect to determine if a patient meets the indications for use for the Barricaid® Annular Closure Device. All instruments are made from stainless steel. This kit is intended to be used only with the Intrinsic Therapeutics Barricaid® Annular Closure Device (ACD).
The purpose of this submission is to modify and reduce the size of the sterilization tray used to contain the reusable instruments necessary to surgically implant or remove the Barricaid® Annular closure device.
V. Indications for Use
The Intrinsic Therapeutics Defect Measurement Tool for the Barricaid® Annular Closure Device is intended to aid in determining if a patient meets the indications for use defined for the Barricaid® Annular Closure Device by assessing the defect size in the annulus fibrosus following limited discectomy. This tool is indicated to only be used with the Intrinsic Therapeutics Barricaid® Annular Closure Device.
VI. Comparison of Technological Characteristics with the Predicate Device
The instruments included in the subject Barricaid® Instrument Kit are identical to the kit in the previously approved kit (P160050) and include the Defect Measurement Tools, Alignment Trials, Slotted Mallet, and the Retraction Wedge. The dimension of the sterilization tray is reduced from the predicate sterilization tray. The sterilization tray is comprised of stainlesssteel, and the brackets composed of stainless-steel or silicone material, which is identical to the predicate.
VII. Performance Data
-
. Bench Testing
Scientific evaluation of sterilization validation and cleaning validation based on worst case. Scientific evaluation of shipping condition based on worst case and market history. -
Clinical Testing .
No new clinical testing was performed. -
Biocompatibility .
No new biocompatibility testing was performed.
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VIII. Conclusion
Based on the changes to the tray, the risk analysis, rationale and previous testing demonstrated that there are no additional risks that have been detected beyond acceptance level. The bench testing conducted supports the proposed device as substantially equivalent to the predicate device (Defect Measurement Tool (Product Code QHG, Regulation 21 CFR 888.4510)).