(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical characteristics of a suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
Explanation: The device is intended for soft tissue fixation and reattachment in the shoulder for various repair procedures, which qualifies it as a therapeutic device.
No
The device is described as a suture anchor intended for soft tissue fixation and reattachment in the shoulder, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical suture anchor made of PEEK with preloaded sutures, intended for surgical implantation. This is a hardware device, not software.
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 "soft tissue fixation" and "soft tissue reattachment procedures in the shoulder." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "soft tissue anchor" with "preloaded nonabsorbable polyethylene surgical sutures used to repair and reattach soft tissue to bone." This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The ALLthread PEEK Suture Anchors are soft tissue anchors with preloaded nonabsorbable polyethylene surgical sutures used to repair and reattach soft tissue to bone and are supplied in both double and triple loaded suture configurations. The ALLthread PEEK Suture Anchors are designed to reattach soft tissue to bone in procedures in the shoulder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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)
Non-Clinical Tests:
Suture tensile strength testing of the ALLthread PEEK Suture Anchor device was performed to verify the strength of the sutures. The test results indicate that the device modifications do not introduce any new risks to implant performance. Cyclic loading testing of the ALLthread PEEK Suture Anchors was performed to verify cyclic performance of the threaded anchor implant. The test results indicate that the device and accessory modifications do not introduce any new risks to implant performance.
Static load testing of the ALLthread PEEK Suture Anchors was performed to verify the pull out strength of the device. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
Insertion torque testing of the ALLthread PEEK Suture Anchors and taps was performed to verify the measured insertion torque or the anchors and taps. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
Needle attachment strength testing of the ALLthread PEEK Suture Anchor devices was performed to verify the minimum force required to detach the suture from needle. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011 as a part of cleaning validation was performed, demonstrating that the device meets the limit of Medical Devices -Bacterial Endotoxin and Pyrogen Tests.
Clinical Tests:
None provided
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.
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
§ 888.3040 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 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.
March 5, 2020
Biomet Inc. Haley Pioch Sr. Regulatory Affairs Specialist 56 East Bell Drive, PO Box 587 Warsaw, Indiana 46581
Re: K193402
Trade/Device Name: ALLthread PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: December 5, 2019 Received: December 6, 2019
Dear Ms. Pioch:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Laura C. Rose, Ph.D. Acting 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
Indications for Use
510(k) Number (if known) K193402
Device Name ALLthread PEEK Suture Anchors
Indications for Use (Describe)
The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
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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3
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 ALLthread PEEK Suture Anchor 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 September 13, 2019.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Haley Pioch
Sr. Regulatory Affairs Specialist
Telephone: (412-376-2510 extension 214) |
| Secondary Contact Person: | Jared Cooper
Regulatory Affairs Manager
Telephone: (574-372-1941) |
| Date: | December 05, 2019 |
| Subject Device: | Trade Name: ALLthread PEEK Suture Anchor
Common Name: Suture Anchor |
| | Classification Name: |
| | MBI - Fastener, Fixation, Nondegradable, Soft Tissue, Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)HWC- screw, fixation, bone (21 CFR 888.3040) |
Predicate Device(s):
| Primary Predicate3 | 510(k) Number |
|---|---|
| ALLthread PEEK Suture Anchor | K060693 |
| ALLthread PEEK Suture Anchor | K080088 |
| Purpose and Device Description: | The ALLthread PEEK Suture Anchors are soft tissue
anchors with preloaded nonabsorbable polyethylene surgical
sutures used to repair and reattach soft tissue to bone and are
supplied in both double and triple loaded suture
configurations. The ALLthread PEEK Suture Anchors are
designed to reattach soft tissue to bone in procedures in the
shoulder. |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The purpose of this submission is:
To submit a 510(k) for cumulative changes: Line extension including device configurations with 2 or 3 suture options, a white/black suture option, a white/green suture option and a tapered needle option. To update labeling in order to narrow the Indications for Use statements, describe the third suture options, and bring the Instructions for Use up to current practices; To ensure that the all of the instrumentation/accessories for use with this system are appropriately associated with a 510(k). |
| Intended Use and
Indications for Use: | The ALLthread PEEK Suture Anchor devices are intended for soft tissue fixation.
The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder.
Specific indications for the shoulder include: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on consideration of the following characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics: Intended Use: Identical to predicate Indications for Use: Similar to predicate Materials: Similar to predicate Design Features: Similar to predicate Sterilization: Similar to predicate |
| Summary of Performance Data:
(Nonclinical and/or Clinical) | Non-Clinical Tests:
Suture tensile strength testing of the ALLthread PEEK Suture Anchor device was performed to verify the strength of the sutures. The test results indicate that the device modifications do not introduce any new risks to implant performance. Cyclic loading testing of the ALLthread PEEK Suture Anchors was performed to verify cyclic performance of the threaded anchor implant. The test results indicate that the device and accessory modifications do not introduce any new risks to implant performance. |
4
5
- Static load testing of the ALLthread PEEK Suture ● Anchors was performed to verify the pull out strength of the device. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- Insertion torque testing of the ALLthread PEEK . Suture Anchors and taps was performed to verify the measured insertion torque or the anchors and taps. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- . Needle attachment strength testing of the ALLthread PEEK Suture Anchor devices was performed to verify the minimum force required to detach the suture from needle. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ● ST 72:2011 as a part of cleaning validation was performed, demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices -Bacterial Endotoxin and Pyrogen Tests.
Clinical Tests:
-
. None provided
The subject ALLthread PEEK Suture Anchor has the same intended use and similar indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, and the information provided herein demonstrates that: -
any differences do not raise new questions of safety ● and effectiveness; and
-
the subject device is at least as safe and effective as the legally marketed predicate devices.
Substantial Equivalence Conclusion: