(197 days)
The Spiralok Anchor is intended for: Shoulder: Rotator cuff repair.
The SpiraLok Anchor, like the current BioFastin RC Anchor, is a PLA threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocord composite suture options may include tapered needles to facilitate suture passage through tissue. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process.
The provided document is a 510(k) summary for a medical device (Spiralok Anchor) and focuses on demonstrating substantial equivalence to a predicate device (BioFastin RC Anchor). It does not contain information about clinical studies with acceptance criteria, device performance metrics, or study design details in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.
Therefore, the requested information cannot be fully provided from the given text. Here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Device Performance (Not Applicable/Not Provided for this Type of Device)
This 510(k) pertains to a physical medical device (suture anchor), not an AI/SaMD. The "acceptance criteria" here are based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical laboratory testing and by showing that dimensional and material changes do not affect safety or effectiveness. Specific performance metrics like sensitivity, specificity, or F1-score, which are common for AI/SaMD, are not relevant or provided for this type of device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Met for Substantial Equivalence) | Reported Device Performance / Evidence |
|---|---|---|
| Material Safety | Biocompatibility, appropriate material properties for absorbable fixation (PLA) | Non-clinical laboratory testing (implied to match or be equivalent to predicate) |
| Dimensional Equivalence | Minor variations from predicate not impacting safety/effectiveness | Description of minor dimensional changes (detailed in Section 2, but not provided in extract) |
| Suture Option Safety | Inclusion of composite Orthocord suture does not compromise safety/effectiveness | Orthocord previously cleared by FDA (K040004) for general soft tissue approximation, including orthopedic surgeries. |
| Intended Use Equivalence | Device maintains the same intended use as the predicate | Stated that changes do not alter intended use (Shoulder: Rotator cuff repair). |
| Fundamental Scientific Technology Equivalence | Device operates on the same core principles as the predicate | Stated that changes do not alter fundamental scientific technology. |
1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Information Not Provided: The document mentions "Non-clinical laboratory testing was performed," but does not detail sample sizes, specific test protocols, or data provenance for these non-clinical tests. This is a physical device, and these would likely be engineering or bench tests rather than clinical studies with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable: For a physical device undergoing non-clinical laboratory testing, "ground truth" and expert consensus in the context of diagnostic interpretation (like for AI/SaMD) are not relevant. Testing would involve engineering measurements and material property assessments against established standards or predicate device performance.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are typically associated with human interpretation of data in clinical studies, not non-clinical laboratory testing of a physical implant.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is a physical medical implant, not an AI/SaMD. MRMC studies or human reader improvement with AI assistance are not relevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical implant, not an algorithm or SaMD.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional sense: For non-clinical lab testing of a physical implant, "ground truth" would be established by validated measurement techniques, material specifications, and engineering principles, often by comparison to the established performance of the predicate device under simulated conditions.
7. The sample size for the training set
- Not Applicable: This device is not an AI/SaMD and does not involve "training sets" in the context of machine learning.
8. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI/SaMD, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria (from the provided text):
The document states that the determination of substantial equivalence was based on a detailed device description and changes made to currently marketed devices. "Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended."
The core of the "study" demonstrating the Spiralok Anchor met the criteria for substantial equivalence involved showing that:
- Dimensional changes from the predicate BioFastin RC Anchor were minor and did not affect safety or effectiveness.
- Material changes (specifically the inclusion of the Orthocord suture option) were safe, as Orthocord was previously cleared by the FDA (K040004) for orthopedic surgeries.
- These changes did not alter the intended use, safety, effectiveness, or fundamental scientific technology of the predicate device.
The specific details of the "non-clinical laboratory testing" (e.g., specific tests, precise methodologies, number of units tested, results in terms of strength, degradation, etc.) are not included in this 510(k) summary, but are implicitly assumed to have been robust enough to satisfy the FDA's requirements for substantial equivalence.
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K041069 page '1 of 2
NOV - 9 2004
SECTION 9 -- 510(k) SUMMARY
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone:781-251-2794Facsimile:781-278-9578e-mail:abarford@dpyus.jnj.com |
| Name of Medical Device | Device Regulation:Fastener, Fixation, Biodegradable, Soft Tissue(21 CFR 888.3030)Product code: 87 MAICommon/Usual Name:Biodegradable Fixation FastenerProprietary Name:Spiralok Anchor |
| Device Classification | Suture Anchors are classified by the FDA as Class II Medical Devices.Absorbable PLA Suture Anchors carry a FDA product code 87 MAI,and are classified as Fastener, Fixation, Biodegradable, Soft Tissueunder 21 CFR 888.3030. |
| Indications for Use | The Spiralok Anchor is intended for:Shoulder: Rotator cuff repair. |
| Device Description | The SpiraLok Anchor, like the current BioFastin RC Anchor, is a PLAthreaded suture anchor preloaded on a disposable inserter assemblyintended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocordcomposite suture options may include tapered needles to facilitatesuture passage through tissue. The attached suture is then used toreattach soft tissue back to bone where it reconnects through the healing |
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process. The changes being made from the predicate BioFastin RC Anchor to Substantial Equivalence the proposed Spiralok Anchor are either dimensional or material changes. The dimensional changes are minor (as described in detail in Section 2 - Device Description) and do not affect the safety or effectiveness of the device. The second change is a material change to include a third suture option, composite Orthocord (K040004). Orthocord suture was previously cleared by FDA for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries. The addition of Orthocord suture option and the dimensional changes made to the design of the anchors do not alter the intended use. safety and effectiveness or the fundamental scientific technology of the predicate device. Mitek believes that the Spiralok Anchor is substantially equivalent to Mitek's BioFastin RC Anchor (K021883). A statement of substantial equivalence is provided in Section 3 and the 510(k) "Substantial Equivalence" Decision-Making Process is attached in Appendix III. Safety and Performance The determination of substantial equivalence for this device was based on a detailed device description and changes that intend to be made to currently marketed devices. Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended.
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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2004
Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs Depuy Mitek A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041069
Trade/Device Name: Spiralok Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HWC, MAI Dated: August 13, 2004 Received: August 16, 2004
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 -- Ms. Ruth C. Forstadt
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of of
510(k) Number (if known): K041069
Device Name: Spiralok Anchor
The Spiralok Anchor is intended for: Shoulder: Rotator cuff repair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Y A (Per 21 CFF 801.109)
Over-the _Counter Use OR
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Premarket Notification: Traditional Spiralok Anchors
510(k) Number
Confidential vi
§ 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.