(156 days)
The Medline UNITE® Snap-Off Screws are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.
The Medline UNITE® Snap-Off Screws are manufactured from titanium alloy. The screws include a groove between the head and the drive mechanism that is intended to snap off the drive mechanism below the surface of the head of the screw. The screws are offered in various diameters, lengths, and thread lengths.
The provided documents describe a 510(k) premarket notification for the Medline UNITE® Snap-Off Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies you've outlined.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- Number of experts used or their qualifications for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission utilizes non-clinical testing to demonstrate that the new device does not present a new worst-case scenario compared to the predicate device in terms of torsional or pullout strength. It explicitly states, "Summary of Clinical Testing: Not applicable."
The core of this 510(k) submission is to demonstrate:
- Same Intended Use: Both the predicate and subject device are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation.
- Same Indications for Use.
- Same Materials: Both are manufactured from titanium alloy (Ti-6AL-4V).
- Similar Design Features: Although the subject device introduces a snap-off mechanism and a three-pronged external drive, the overall function as a bone fixation fastener is similar to the predicate cannulated screws.
- Non-clinical Testing: The critical aspect highlighted is that "The subject screw does not present a new worst-case when compared to the predicate screw in torsional or pullout strength." This is the primary "proof" of equivalence for mechanical properties.
In summary, this document supports the substantial equivalence of a medical device by comparing its characteristics and performance to an already legally marketed predicate device, primarily through engineering and material compatibility, and demonstrating no new worst-case performance in relevant mechanical tests, rather than establishing and meeting specific performance acceptance criteria through clinical or AI-specific validation studies as described in your request.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093
Re: K170782
Trade/Device Name: Medline UNITE® Snap-Off Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 2, 2017 Received: August 3, 2017
Dear Jennifer Mason:
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 Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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
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Indications for Use
510(k) Number (if known)
Device Name Medline UNITE® Snap-Off Screws
Indications for Use (Describe)
The Medline UNITE® Snap-Off Screws are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.
| 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 shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, bold, sans-serif font. Above and below the text is a white, stylized starburst symbol that is vertically oriented.
ledline Industries, Inc. Three Lakes Drive Northfield, IL 60093
K170782 PAGE 1 OF 2
510(K) Summary [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date August 1, 2017
Type of 510(k) Submission Special
Device Name / Classification
Name of Device: Medline UNITE® Snap-Off Screws Proprietary Name: Medline UNITE® Snap-Off Screws Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Product Code: HWC Classification Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3040
Predicate Device
Medline Cannulated Screw K130319
Additional Predicate Device
Wright Medical CHARLOTTE™ Snap-Off Screw K133713
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
K170782 PAGE 2 OF 2
Device Description
The Medline UNITE® Snap-Off Screws are manufactured from titanium alloy. The screws include a groove between the head and the drive mechanism that is intended to snap off the drive mechanism below the surface of the head of the screw. The screws are offered in various diameters, lengths, and thread lengths.
Indications for Use
The Medline UNITE® Snap-Off Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Summary of Technological Characteristics
The proposed modified device is substantially equivalent to the predicate, the Medline Cannulated Screw. Both devices have the same intended use, same indications for use, same materials (Ti-6AL-4V), are provided non-sterile and have similar design features. The predicate Snap-Off Screws are offered in 2.0 and 2.7mm diameters in lengths from 11-21mm, which is within the previously cleared range for the Medline Cannulated Screws including 2.0-7.5mm diameters in lengths from 10-130mm.
Both the subject and the predicate screws are partially threaded, self-tapping. In addition, both the subject and predicate screw incorporate a drive feature; for the subject Snap-Off Screw the drive feature is attached to the screw and breaks away during insertion and ther is a three pronged external drive feature used for finally seating the screw, the predicate Medline Cannulated Screws incorporate various size torx drives.
Summary of Non-Clinical Testing
The subject screw does not present a new worst-case when compared to the predicate screw in torsional or pullout strength.
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline UNITE® Snap-Off Screws are safe, effective and substantially equivalent to the predicate, the Medline Cannulated Screw.
N/A