(284 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a surgical implant, with no mention of AI or ML technologies.
Yes.
The device is an implantable system designed for reconstruction and fusion of lesser toes, directly addressing a medical condition.
No
The device is an implantable system used for hammertoe correction, which is a treatment or reconstruction, not a diagnostic procedure.
No
The device description clearly states it is an implant made of Titanium, which is a physical hardware component, not software.
No, 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 Description: The Life Spine HAMMERTOE Correction System is an implant designed for surgical insertion into the body to correct a physical condition (hammertoe). It is a physical device used in vivo (within the living body), not a test performed in vitro (outside the living body).
- Intended Use: The intended use is for "small bone reconstruction limited to inter-digital repar and fusion of the lesser toes," which is a surgical procedure.
The provided information clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repar and fusion of the lesser toes.
Product codes
HWC
Device Description
The Hammertoe Correction System is an implant with dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from Titanium (Ti 6A1-4V ELI)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Hammertoe Correction System components with components from any other system or manufacturer. The Hammertoe Correction System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inter-digital repar and fusion of the lesser toes
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)
Finite Element Analysis, Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the Life Spine Hammertoe Correction System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2016
Life Spine, Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K153065
Trade/Device Name: The Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 27, 2016 Received: May 31, 2016
Dear Mr. Lewis:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
The Hammertoe Correction System
Indications for Use (Describe)
The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repar and fusion of the lesser toes.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary Hammertoe Correction System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 27th, 2016 |
| Trade Name: | Hammertoe Correction System |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification: | HWC, CFR 888.3040, Class II |
| Primary Predicate: | Arthrex BioPin (K050259)
Life Spine Cannulated Screws (K150126) |
Device Description:
The Hammertoe Correction System is an implant with dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from Titanium (Ti 6A1-4V ELI)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Hammertoe Correction System components with components from any other system or manufacturer. The Hammertoe Correction System components should never be reused under any circumstances.
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Indications for Use of the Device:
The Hammertoe Correction System is indicated for small bone reconstruction limited to interdigital repair and fusion of the lesser toes.
Technological Characteristics:
The Hammertoe Correction System is substantially equivalent to the predicate system in terms of design, indications for use and sizing.
Material:
The Hammertoe Correction System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of non-sterile titanium, single use components.
Performance Data:
Finite Element Analysis, Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the Life Spine Hammertoe Correction System.
Conclusion:
The information presented demonstrates the substantial equivalency of the Hammertoe Correction System.