(102 days)
No
The summary describes a mechanical surgical device for meniscal repair and does not mention any AI or ML components, image processing, or data-driven performance metrics.
Yes
The device is indicated for "repair of vertical longitudinal full thickness tears" in the meniscus, which describes a therapeutic action.
No
Explanation: The device is indicated for the repair of meniscal tears, which is a therapeutic function, not a diagnostic one. The description outlines a surgical repair device.
No
The device description clearly states it is a "permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves" and comes "pre-assembled on either a Straight or Curved inserter," indicating it is a physical medical device, not software.
Based on the provided information, the JuggerStitch Meniscal Repair Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the repair of meniscal tears, which is a surgical procedure performed in vivo (within the body). IVD devices are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a permanent fixation anchor system comprised of sutures and sleeves, designed to be implanted into the meniscus. This is consistent with a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the JuggerStitch Meniscal Repair Device is a surgical device intended for the treatment of a medical condition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
Product codes
MBI
Device Description
The JuggerStitch Meniscal Repair Device is a permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves. The device comes as a unit, pre-assembled on either a Straight or Curved inserter. The purpose of this submission is to introduce modifications to the Juggerstitch suture implant and inserter for ease of use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Meniscus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Tests:
- Static tensile testing of the JuggerStitch Meniscal Repair Device was performed to verify the strength of the implant. The test results indicate that the device modifications do not introduce any new risks to implant performance.
- Cantilever bend testing of the JuggerStitch inserter needles was performed to verify the bending strength of the devices. The test results indicate that the device and accessory modifications do not introduce any new risks to needle performance.
- Tissue penetration force testing of the JuggerStitch inserter needles was performed to verify the penetration force of the devices. The test results indicate that the device and accessory modifications do not introduce any new risks to needle performance.
- Advancement testing of the JuggerStitch depth adjuster was performed to verify the force required to advance the depth adjuster. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- Advancement testing of the JuggerStitch push button was performed to verify the force required to advance the push button. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- A surgeon validation was performed to assess if the JuggerStitch Meniscal Repair Devices meet its intended User Needs. The test results show that the device does perform as intended.
- Sterilization validations were performed on the JuggerStitch Meniscal Repair Devices. The test results show that the devices meet the requirements of ISO 11135 and ISO 11137 as applicable.
- Packaging validations were performed on the packaging configurations of the JuggerStitch Meniscal Repair Devices. The test results show that the devices meet the requirements of ISO 11607.
Clinical Tests:
- Clinical data was not required to establish substantial equivalence between the subject JuggerStitch Meniscal Device and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Biomet Inc. Kyle Ponce Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K191459
Trade/Device Name: JuggerStitch Meniscal Repair Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 12, 2019 Received: August 13, 2019
Dear Mr. Ponce:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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
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Indications for Use
510(k) Number (if known) K191459
Device Name JuggerStitch Meniscal Repair Device
Indications for Use (Describe)
The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. buckethandle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
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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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the JuggerStitch Meniscal Repair Device 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------|
| Contact Person: | Kyle Ponce
Regulatory Affairs Specialist
Telephone: (973-299-9300 EXT 2125)
Fax: fax (574-372-1718) | | |
| Date: | May 31, 2019 | | |
| Subject Device: | Trade Name: JuggerStitch Meniscal Repair Device
Common Name: Soft Tissue Fixation Device | | |
| | Classification Name:
• MBI– Fastener, Fixation, Nondegradable, Soft Tissue
(21 CFR 888.3040) | | |
| Predicate Device(s): | | | |
| | 510(K) Number | Device | Manufacturer |
| | K150424 | JuggerStitch Meniscal
Repair Device (Primary
Predicate) | Biomet Sport
Medicine |
| | K061776 | MaxFire Meniscal Repair
Device (Reference
Predicate) | Biomet Sport
Medicine |
| Purpose and Device
Description: | The JuggerStitch Meniscal Repair Device is a permanent
fixation anchor system comprised of UHMWPE suture,
with two non-resorbable polyester sleeves. The device
comes as a unit, pre-assembled on either a Straight or
Curved inserter. The purpose of this submission is to
introduce modifications to the Juggerstitch suture implant | | |
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and inserter for ease of use.
Intended Use and Indications for Use:
Summary of Technological Characteristics:
The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Intended use is identical to the ● predicate devices.
- Indications for Use: Indications are identical to the ● predicate devices.
- Materials: Materials are identical to the predicate ● devices.
- o Design Features: Design features are similar to the predicate devices.
- Sterilization: The proposed JuggerStitch Meniscal o Repair Devices are provided sterile via EO, the same sterilization method utilized for the predicate devices.
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: o
- Static tensile testing of the JuggerStitch Meniscal o Repair Device was performed to verify the strength of the implant. The test results indicate that the device modifications do not introduce any new risks to implant performance.
- Cantilever bend testing of the JuggerStitch о inserter needles was performed to verify the bending strength of the devices. The test results indicate that the device and accessory modifications do not introduce any new risks to needle performance.
- Tissue penetration force testing of the O JuggerStitch inserter needles was performed to verify the penetration force of the devices. The test results indicate that the device and accessory modifications do not introduce any new risks to needle performance.
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- Advancement testing of the JuggerStitch depth o adjuster was performed to verify the force required to advance the depth adjuster. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- Advancement testing of the JuggerStitch push o button was performed to verify the force required to advance the push button. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- A surgeon validation was performed to assess if O the JuggerStitch Meniscal Repair Devices meet its intended User Needs. The test results show that the device does perform as intended.
- Sterilization validations were performed on the o JuggerStitch Meniscal Repair Devices. The test results show that the devices meet the requirements of ISO 11135 and ISO 11137 as applicable.
- Packaging validations were performed on the O packaging configurations of the JuggerStitch Meniscal Repair Devices. The test results show that the devices meet the requirements of ISO 11607.
0 Clinical Tests:
- o Clinical data was not required to establish substantial equivalence between the subject JuggerStitch Meniscal Device and the predicate devices.
Substantial Equivalence Conclusion
The proposed JuggerStitch Meniscal Repair Devices have been shown to be substantially equivalent to the predicate devices. Results of preclinical tests and the similarities with predicate devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised.