(70 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture anchor, with no mention of AI/ML technology or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML. The "A.I.M." in the name appears to be a product name, not an indicator of AI technology.
No.
The device is a suture anchor used for fixation of soft tissue to bone, which is a surgical tool rather than a therapeutic device that directly treats a condition or disease.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device is a suture anchor intended for fixation of soft tissue to bone during surgical procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a physical implant system including a PEEK anchor, inserter, and suture, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of soft tissue to bone" in surgical procedures. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a physical implant (suture anchor) and its components used in surgery. This is consistent with a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The A.I.M. TM Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.
The A.I.M. TM Suture Anchor is intended for use in the following applications:
Ankle: Mid-foot Reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction
Product codes
MBI
Device Description
The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle: Mid-foot
Foot: Hallux valgus
Hand: Ulnar or lateral collateral ligament
Wrist: Scapholunate ligament
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)
Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device. Biocompatibility of the anchor was established through reference to data on file from the provider of the PEEK material.
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.
0
OCT 1 6 2013
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
Name: Anchor Innovation Medical, Inc.
..
Howard Schrayer Contact: Regulatory Consultant
Address: Anchor Innovation Medical, Inc. 5410 Edson Lane, Suite 308 Rockville, MD 20852
| Telephone: | 978-969-0070 |
|---|---|
| Fax: | 978-969-0169 |
| Date Prepared | October 7, 2013 |
General Device Information
Product Name: A.I.M.™ Suture Anchor
Classification: "Non-degradable soft tissue fixation fastener" Product code: MBI - Class II
Predicate Device
| Smith & Nephew, Inc. | Bioraptor™ 2.3 PK Suture Anchor.
[510(k) Number K071586] |
|----------------------|-----------------------------------------------------------------|
| Mitek, Inc. | MiniLok Quick Anchor Plus™
Suture Anchor
[510(k) K030995] |
1
Description
The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl
Intended Use (Indications)
The A.I.M. ™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.
The A.I.M. ™ Suture Anchor is intended for use in the following applications:
- Ankle: Mid-foot Reconstruction .
- Foot: Hallux valgus reconstruction o
- Hand: Ulnar or lateral collateral ligament reconstruction ●
- Wrist: Scapholunate ligament reconstruction .
Substantial Equivalence
This submission supports the position that the A.I.M.™ Suture Anchor is substantially equivalent to previously cleared devices, including those listed above. Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device. Biocompatibility of the anchor was established through reference to data on file from the provider of the PEEK material. The referenced predicate devices include the same range of clinical uses in their labeling.
Conclusions
Anchor Innovation Medical, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the A.J.M.™ Suture Anchor. The materials from which the Anchor Innovation Medical device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines. The A.I.M. ™ Suture Anchor is substantially equivalent to previously marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2013
Anchor Innovation Medical, Incorporation Mr. Howard Schrayer Regulatory Consultant 5410 Edson Lane, Suite 308 Rockville, Maryland 20852
Re: K132461
Trade/Device Name: A.I.M. "" Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 28, 2013 . Received: August 29, 2013
Dear Mr. Schrayer:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Howard Schrayer
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,
Erini DKeith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K132461
Device Name: A.I.M.™ Suture Anchor
Indications For Use:
The A.I.M.™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.
The A.I.M. ™ Suture Anchor is intended for use in the following applications:
AND/OR
Ankle: Mid-foot Reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices