(189 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the bone anchor, with no mention of AI or ML.
Yes
The device is intended for the reattachment of soft tissue to bone for specific indications like tendon and ligament reconstruction and repair, which are therapeutic interventions.
No
The device description clearly states it is a bone anchor intended for reattachment of soft tissue to bone, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components made of nickel-titanium and PEEK, preloaded on a disposable delivery instrument. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for reattaching soft tissue to bone. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implantable device made of nickel-titanium and PEEK, preloaded on a delivery instrument. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
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 Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction - Scapholunate ligament reconstruction - Lateral epicondylitis repair.
Product codes
MBI
Device Description
The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2-0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow, Hand and Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Biocompatibility testing was conducted in accordance with ISO 10993-1 standards. Corrosion testing was conducted in accordance with ASTM F2129. Tensile testing was performed to verify compliance with USP suture requirements and comparison testing to support the safety and effectiveness of the Micro/Mini N-PK(H) Bone Anchor included evaluation of fixation/static disassembly strength and cyclic fatigue performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith & Nephew, Inc., Bioraptor PK Suture Anchor (K071586, DePuy Mitek Mini QuickAnchor Plus (K071257)
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
510(k) Summary
K121356
Page 1/2
.
As Required by 21 CFR 807.92
| NOV 9 2012 | |
|---|---|
| Anulex Technologies, Inc. | |
| Submitter: | 5600 Rowland Road, Suite 280 |
| Minnetonka, MN 55343 | |
| Contact Person: | Rachel Kennedy |
| Director, Regulatory Affairs and Quality Systems | |
| Anulex Technologies, Inc. | |
| Direct: 952.224.4034 | |
| Fax: 952.224.5417 | |
| E-Mail: rkennedy@anulex.com | |
| Date Prepared: | October 25, 2012 |
| Trade Name: | Micro/Mini N-PK(H) Bone Anchor |
| Classification: | II |
| Product Code: | MBI |
| 21 CFR 888.3040 | |
| Predicate Device(s): | The subject device is substantially equivalent to the |
| following predicate devices: | |
| Smith & Nephew, Inc., Bioraptor PK Suture Anchor | |
| (K071586 cleared August 17, 2007) DePuy Mitek Mini QuickAnchor Plus (K071257 | |
| cleared June 29, 2007) | |
| Device Description: | The Micro/Mini N-PK(H) Bone Anchor consists of an |
| adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- |
- with one (1) or two (2) attached anchors. The bone
anchor is a two part system, one part nickel-titanium
(nitinol) and the second part polyetheretherketone (PEEK).
The PEEK part resides within the nitinol sleeve and retains
the suture. The nitinol part expands upon delivery
providing resistance to pullout.
The construct is provided sterile and preloaded on a
disposable delivery instrument. |
| Indications for Use: | The Micro/Mini N-PK Bone Anchor is intended for the
reattachment of soft tissue to bone for the following
indications:
Elbow, Hand and Wrist Biceps tendon reattachment Ulnar or lateral collateral ligament |
Anulex Technologies, Inc.
.
K121356A2
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Page 2/2
reconstruction
●
- Scapholunate ligament reconstruction
- Lateral epicondylitis repair ●
Functional and Safety Testing:
Comparison to Predicate:
Conclusion:
Biocompatibility testing was conducted in accordance with ISO 10993-1 standards. Corrosion testing was conducted in accordance with ASTM F2129. Tensile testing was performed to verify compliance with USP suture requirements and comparison testing to support the safety and effectiveness of the Micro/Mini N-PK(H) Bone Anchor included evaluation of fixation/static disassembly strength and cyclic fatigue performance.
The Micro/Mini N-PK(H) Bone Anchor that is the subject of this submission has the same materials and similar technological characteristics in comparison to the predicate suture anchors. The intended use is the same as the predicates, fixation of soft tissue to bone for a variety of orthopedic procedures in the elbow, hand and wrist while the predicate anchors include procedures in additional anatomical locations.
Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance with voluntary performance standards.
Anulex Technologies, Inc.
K121356A2
2
Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 9, 2012
Anulex Technologies, Incorporated % Ms. Rachel Kennedy Director, Regulatory Affairs and Quality Assurance 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K121356
Trade/Device Name: Micro/Mini N-(PK)(H) Bone Anchor Regulation Number: 21 CFR 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: MBI Dated: October 26, 2012 Received: October 31, 2012
Dear Ms. Kennedy:
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 - Ms. Rachel Kennedy
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix 4: Indications for Use Form
KI2i356
Device Name: Micro/Mini N-PK(H) Bone Anchor
Indications for Use:
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Hand and Wrist
- Biceps tendon reattachment
- Ulnar or lateral collateral ligament reconstruction .
- ◆ Scapholunate ligament reconstruction
- . Lateral epicondylitis repair
Prescription Use _________X (Part 21 CFR 801 Subpart D AND/OR
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)
ASh
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K171356
Micro/Mini N-PK(H) Bone Anchor Anulex Technologies, Inc. Confidential
Traditional 510(k) Premarket Notification
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