(189 days)
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle - . Hallux valgus repairs - Medial or lateral instability repairs/reconstructions . - Achilles tendon repairs/reconstructions - . Midfoot reconstructions - Metatarsa} ligament/tendon repairs/reconstructions . - . Bunionectomy
The Micro/Mini N-PK(F) 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.
The provided text describes a medical device, the Micro/Mini N-PK(F) Bone Anchor, and its substantial equivalence to predicate devices, but it DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance.
The document is a 510(k) summary for a physical medical device (a bone anchor) and focuses on demonstrating substantial equivalence through materials, technological characteristics, and performance testing typically associated with mechanical medical devices (biocompatibility, corrosion, tensile, fixation strength, cyclic fatigue).
Therefore, I cannot extract the requested information using the provided text. The questions you've asked are relevant to the evaluation of AI/ML-driven medical devices, which this document does not cover.
To elaborate on why the requested information cannot be found:
- A table of acceptance criteria and the reported device performance: The document mentions "Functional and Safety Biocompatibility testing," "Corrosion testing," "Tensile testing," and "fixation/static disassembly strength and cyclic fatigue performance." However, it does not provide specific acceptance criteria (e.g., minimum tensile strength value, maximum corrosion rate) or the quantitative results of these tests in a table. It only states that these tests were "conducted" or "performed to verify compliance" or "support safety and effectiveness."
- Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. For a mechanical device, "ground truth" would be the measured physical properties or performance under stressed conditions.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
This document describes a traditional medical device submission, not one for an AI/ML-enabled product.
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Appendix 5: 510(k) Summary
大121354
As Required by 21 CFR 807.92
| Submitter: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 |
|---|---|
| Contact Person: | Rachel KennedyDirector, Regulatory Affairs and Quality SystemsAnulex Technologies, Inc.Direct: 952.224.4034Fax: 952.224.5417E-Mail: rkennedy@anulex.com |
| Date Prepared: | October 25, 2012 |
| NOV 9 2012 | |
| Trade Name: | Micro/Mini N-PK(F) Bone Anchor |
| Classification: | II |
| Product Code: | MBI |
| 21 CFR 888.3040 | |
| Predicate Device(s): | The subject device is substantially equivalent to thefollowing predicate devices:• Smith & Nephew, Inc., Bioraptor PK Suture Anchor(K071586 cleared August 17, 2007)• DePuy Mitek Mini QuickAnchor Plus (K071257cleared June 29, 2007) |
| Device Description: | The Micro/Mini N-PK(F) Bone Anchor consists of anadjustable loop of non-absorbable suture (Sizes 2, 0 and 2-0)with one (1) or two (2) attached anchors. The bone anchoris a two part system, one part nickel-titanium (nitinol) andthe second part polyetheretherketone (PEEK). The PEEKpart resides within the nitinol sleeve and retains the suture.The nitinol part expands upon delivery providing resistanceto pullout.The construct is provided sterile and preloaded on adisposable delivery instrument. |
| Indications for Use: | The Micro/Mini N-PK Bone Anchor is intended for thereattachment of soft tissue to bone for the followingindications:Foot and Ankle• Hallux valgus repairs |
Anulex Technologies, Inc.
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- Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions � Midfoot reconstructions ● Metatarsal ligament/tendon ● repairs/reconstructions . Bunionectomy Functional and Safety Biocompatibility testing was conducted in accordance with ISO 10993-1 standards. Corrosion testing was conducted in Testing: 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(F) Bone Anchor included evaluation of fixation/static disassembly strength and cyclic fatigue performance. The Micro/Mini N-PK(F) Bone Anchor that is the subject of Comparison to Predicate: 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 foot and ankle while the predicate anchors include procedures in additional anatomical locations. Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance Conclusion: with voluntary performance standards.
0
K121354A2
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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 stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K121354
Trade/Device Name: Micro/Mini N-(PK)(F) 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 connisted pror to 1125 2011-11-11 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. Troumly, therefere, maxisions of the Act include requirements for annual registration, listing of I ho general vont ons proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Trease noter u, 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 may be subject to additions, 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 i Tease of advised that I Dris issuants over device complies with other requirements of the Act that I Dr Has made a word regulations administered by other Federal agencies. You must of any I color statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI it Fart 607); aboning (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Rachel Kennedy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand of ovisions (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/ucm 115809.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 note and regalations 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
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Appendix 4: Indications for Use Form
Device Name: Micro/Mini N-PK(F) 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:
Foot and Ankle
- . Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions .
- Achilles tendon repairs/reconstructions
- . Midfoot reconstructions
- Metatarsa} ligament/tendon repairs/reconstructions .
- . Bunionectomy
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Asto
(Division Sign-Oft) Division of Surgical, Ort- Spedic, and Restorative Devices
510(k) Number K121354
Micro/Mini N-PK(F) Bone Anchor Anulex Technologies, Inc. Confidential
" .
Traditional 510(k) Premarket Notification
Page 52
§ 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.