(167 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical technique of a physical implant, with no mention of AI or ML.
Yes.
The device is used to provide tibial suspensory fixation, supporting a tendon graft until aperture healing occurs and the graft integrates with the bone, which facilitates the healing process after orthopaedic reconstruction procedures. This directly aids in the restoration of normal function or health.
No
The device is a PEEK cortical tibial suspensory fixation device used for tibial fixation of biological ligament during orthopedic reconstruction procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical PEEK cortical tibial suspensory fixation device, not software. The performance studies involve in-vitro testing on cadaveric tibiae, which is hardware-related testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "PEEK cortical tibial suspensory fixation device" that functions by physically securing a ligament graft within the bone. This is a mechanical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health or condition. This device does not perform any such analysis.
The information clearly indicates that this is a surgical implant used for mechanical fixation within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and functions via the looping of a biological or artificial tendon graft through the loop component of the device. The tendon graft is then pulled through the tibial and femoral tunnels. The wing components of the device rest on the tibial cortex, facilitating tensioning on the femoral side (if required). The device then provides tibial suspensory fixation, supporting the graft until aperture healing occurs and the graft integrates with the bone, at which point the device does not bear load and is redundant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial, Femoral
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)
Comparative in-vitro testing on human cadaveric tibiae was performed and the results for ANCHORMAN were compared to that of the predicate. The results showed that ANCHORMAN possesses mechanical, chemical, physical and handling characteristics necessary to demonstrate that it is substantially equivalent to Retrobutton.
Direct comparative performance testing in cadaveric tibiae comparing ANCHORMAN and the predicate device has confirmed that, when the relevant performance/ clinical characteristics which may be affected by size (UTS, initial and cyclic displacement and stiffness) are equivalent with reference to the clinically identified failure levels.
Direct comparative performance testing in human cadaveric tibiae comparing ANCHORMAN and the predicate device has confirmed that, when implanted properly, the relevant performance/ clinical characteristics which may be affected by size (UTS, initial and cyclic displacement and stiffness) are equivalent with reference to the clinically identified failure levels. The cadaveric usability study for ANCHORMAN has demonstrated the appropriateness of this technique for users, even in worst case insertion and removal circumstances.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Summit Medical Ltd. Sam Drew RA Manager - Projects Bourton Industrial Park Bourton on the Water, Gloucestershire GL54 2HO United Kingdom
July 25, 2017
Re: K170388
Trade/Device Name: ANCHORMAN Tibial Ligament Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 14, 2017 Received: June 14, 2017
Dear Sam Drew:
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
1
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 devicerelated 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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Page 1 of 1
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170388
Device Name
ANCHORMAN Tibial ligament fixation device
Indications for Use (Describe)
Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction
| 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 – K170388 Summit Medical Ltd ANCHORMAN
SUMMIT MEDICAL
SURGICAL PRODUCTS
SURGICAL PRODUCTS
Head office OrthoD Group Ltd Industrial Park Bourton on the Water Gloucestershire GL54 2HQ United Kingdom
+44 (0) 1451 821311 tel. info@orthod.com email website www.orthod.com
| Date prepared | 31/May/2017 |
|---|---|
| Submitter | Summit Medical Ltd |
| Contact person | Sam Drew |
| RA Manager - Projects | |
| Summit Medical | |
| Industrial Park | |
| Bourton-on-the-Water | |
| Gloucestershire | |
| GL54 2HQ | |
| Phone: +44(0)1451 823350 | |
| Fax: +44 (0)1451 821092 | |
| Email: sam.drew@orthod.com | |
| Name of device | ANCHORMAN cortical tibial fixation device |
| Classification | Classification - II |
| Product Code - MBI | |
| Classification name - Fastener, Fixation, Nondegradable, Soft Tissue | |
| Classification Rule - 888.3040 | |
| Device Panel – 87 - "Orthopedic surgery" | |
| Predicate device(s) | Arthrex Inc., Retrobutton cleared under K062747 |
| Indications for use | Tibial fixation of biological ligament during orthopaedic reconstruction |
| procedures such as Anterior Cruciate Ligament (ACL) reconstruction | |
| Device description | ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and |
| functions via the looping of a biological or artificial tendon graft through the | |
| loop component of the device. The tendon graft is then pulled through the | |
| tibial and femoral tunnels. The wing components of the device rest on the | |
| tibial cortex, facilitating tensioning on the femoral side (if required). The | |
| device then provides tibial suspensory fixation, supporting the graft until | |
| aperture healing occurs and the graft integrates with the bone, at which point | |
| the device does not bear load and is redundant. |
4
510(k) Summary Summit Medical Ltd ANCHORMAN
MMIT MEDICAL
SURGICAL PRODUCTS
| Non-clinical testing | Comparative in-vitro testing on human cadaveric tibiae was performed and
the results for ANCHORMAN were compared to that of the predicate. The
results showed that ANCHORMAN possesses mechanical, chemical, physical
and handling characteristics necessary to demonstrate that it is substantially
equivalent to Retrobutton. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical testing | Clinical data was not required to establish substantial equivalence between
the ANCHORMAN and the predicate device. |
| Chemical differences | Although ANCHORMAN and the predicate are composed of different
materials, and therefore have chemical differences, both PEEK
(ANCHORMAN), UHMWPE and Titanium Ti6Al4V (RetroButton) are long
established implant materials, with confirmatory biocompatibility testing
verifying this. Comparative in-vitro testing on human cadaveric tibiae was
performed and the results for ANCHORMAN were compared to that of the
predicate, and showed that the chemical differences between ANCHORMAN
and the predicate do not raise any new questions of safety and effectiveness |
| Physical differences | Although ANCHORMAN and the predicate have different designs and
materials, direct comparative performance testing in cadaveric tibiae
comparing ANCHORMAN and the predicate device has confirmed that, when
the relevant performance/ clinical characteristics which may be affected by
size (UTS, initial and cyclic displacement and stiffness) are equivalent with
reference to the clinically identified failure levels. |
| Handling differences | Direct comparative performance testing in human cadaveric tibiae comparing
ANCHORMAN and the predicate device has confirmed that, when implanted
properly, the relevant performance/ clinical characteristics which may be
affected by size (UTS, initial and cyclic displacement and stiffness) are
equivalent with reference to the clinically identified failure levels. The
cadaveric usability study for ANCHORMAN has demonstrated the
appropriateness of this technique for users, even in worst case insertion and
removal circumstances. These differences do not raise any new questions of
safety and effectiveness |
| Substantial equivalence | Based on the similarities in design, function, indications for use and
fundamental scientific technology, the devices that are the subject of this
submission are similar to the predicate devices and do not introduce any new
risks of safety or efficacy. Therefore, Summit Medical concludes that the
subject device is substantially equivalent to the predicate device. |