(112 days)
The A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.
The A.I.M. Lead Loop Suturing Device is a singular anchor threaded with an adjustable loop of non-absorbable size 0 suture. The suture material is commercially available Ultra-High Molecular Weight Polyethylene or Polyester braid. The anchor is composed of carbon fiber reinforced polyetheretherketone (PEEK OPTIMA®) supplied by Invibio®. The device is provided sterile and pre-loaded in a needle-tipped, disposable-delivery device to facilitate insertion into tissue. A sterile, disposable ancillary instrument is available separately, or included with the Lead Loop Suturing Device, to assist with tensioning the construct and trimming the suture once the appropriate tension is achieved.
The provided document describes a medical device, the A.I.M. Lead Loop Suturing Device, and its 510(k) submission for substantial equivalence to a predicate device. The information is related to the regulatory approval process and includes a summary of performance testing, but it does not contain the kind of detailed information about acceptance criteria, specific study designs (like MRMC), expert involvement, or ground truth establishment that would be typically found for an AI/ML-based medical software device.
Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of device being described (a physical suturing device, not an AI/ML diagnostic tool).
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The document states that "Comparative performance testing with the predicate demonstrated equivalent performance and did not raise any new questions of safety or effectiveness." This implies the acceptance criterion was equivalence or non-inferiority to the predicate device in terms of performance and safety.
- Reported Device Performance: "Bench testing was conducted to confirm that the A.I.M. Lead Loop Suturing Device performs as well or better than the predicate in cyclic loading and ultimate device/construct failure."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent or better performance than predicate device in cyclic loading and ultimate device/construct failure. | Performs "as well or better than the predicate in cyclic loading and ultimate device/construct failure." |
| No new questions of safety or effectiveness compared to predicate. | No new questions of safety or effectiveness were raised. |
| Biocompatible according to ISO 10993. | Determined to be biocompatible based on conformity with ISO 10993. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The testing described is "bench testing," which typically involves laboratory simulations, not clinical patient data.
3. 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)
- This information is not applicable/provided. The device is a physical suturing tool, not an AI/ML algorithm requiring expert-labeled ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in clinical trials or for AI/ML performance evaluation, which is not the type of testing described.
5. 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
- This information is not applicable/provided. This type of study relates to AI/ML devices assisting human interpretation, which is not relevant to a physical suturing device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided. This refers to AI/ML algorithm performance, which is not relevant to this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the described bench testing, the "ground truth" would be objective physical measurements of device properties like cyclic loading capacity and ultimate failure strength, compared against the predicate device's known performance or established engineering standards. It is not based on clinical ground truth types like expert consensus or pathology reports.
8. The sample size for the training set
- This information is not applicable/provided. A physical device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- This information is not applicable/provided. As above, there is no "training set" for this type of device.
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Image /page/0/Picture/1 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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2015
Anchor Innovation Medical c/o Karen M. Becker, Ph.D. 5410 Edson Lane, Suite 308 Rockville, MD 20852
Re: K150924
Trade/Device Name: A.I.M. Lead Loop Suturing Device Regulation Number: 21 CFR 882.5880 Regulation Name: Stimulator, Spinal Cord, Implanted (Pain Relief) Regulatory Class: Class II Product Code: GZB and GAT Dated: April 30, 2015 Received: May 1, 2015
Dear Dr. Becker:
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
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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/Resourcesfor You/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 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 yours,
Carlos L. Pena -5-D/Δ
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150924
Device Name
A.I.M. Lead Loop Suturing Device
Indications for Use (Describe)
The A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.
| 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) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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2.0 510(K) SUMMARY: A.I.M. LEAD LOOP SUTURING DEVICE
July 23, 2015 Submission Date:
Submitter Information:
| Company: | Anchor Innovation Medical (A.I.M.)5410 Edson LaneSuite 308Rockville, MD 20852 |
|---|---|
| Contact Person: | Cory Stolneaker |
Contact Person: Cary Stalnecker Chief Executive Officer
Correspondent Information:
Karen M. Becker, Ph.D. 5410 Edson Lane, Suite 308 Rockville, MD 20852
Phone: 301-770-7871 Fax: 301-770-7874 kbecker@anivmed.com
Device Information:
| Trade Name: | A.I.M. Lead Loop Suturing Device |
|---|---|
| Regulation Name: | Stimulator, Spinal Cord, Implanted (Pain Relief) |
| Classification: | 21 CFR 882.5880 |
| Product Codes: | GZB/GAT |
| Device Class: | Class II |
| Predicate Devices: | Boston Scientific Fixate Suturing Device (K113805) |
| Intended Use: | The A.I.M. Lead Loop Suturing Device is intended for use insecuring Spinal Cord Stimulation (SCS) leads and catheters to thefascia or intra-spinous/supra-spinous ligament. |
| Device Description: | The A.I.M. Lead Loop Suturing Device is a singular anchorthreaded with an adjustable loop of non-absorbable size 0 suture.The suture material is commercially available Ultra-HighMolecular Weight Polyethylene or Polyester braid. The anchor iscomposed of carbon fiber reinforced polyetheretherketone (PEEKOPTIMA®) supplied by Invibio®. The device is provided sterileand pre-loaded in a needle-tipped, disposable-delivery device tofacilitate insertion into tissue. A sterile, disposable ancillaryinstrument is available separately, or included with the Lead LoopSuturing Device, to assist with tensioning the construct andtrimming the suture once the appropriate tension is achieved. |
| Substantial EquivalenceSummary: | The A.I.M. Lead Loop Suturing Device is substantially equivalentto the cited predicate, Boston Scientific's Fixate Suturing Device,having the same, or similar, intended use, indications for use, andfundamental scientific technology. |
| The A.I.M Lead Loop Suturing Device and predicate differ insuture anchor count, the means of tensioning and capturing theSCS lead anchor or catheter, and retaining tension. | |
| Comparative performance testing with the predicate demonstratedequivalent performance and did not raise any new questions ofsafety or effectiveness. | |
| Performance Testing: | Bench testing was conducted to confirm that the A.I.M. Lead LoopSuturing Device performs as well or better than the predicate incyclic loading and ultimate device/construct failure. |
| Safety Testing: | The A.I.M. Lead Loop Suturing Device was determined to bebiocompatible based on conformity with ISO 10993. Componentmaterials and assembly processes are identical or similar to thoseutilized within the A.I.M Knotless Meniscal Repair Device(K133770) and Suture Anchor (K132461). |
| Conclusion: | Based on the similarity in intended use, materials, fundamentalscientific technology and performance testing, the A.I.M. LeadLoop Suturing Device is substantially equivalent to the citedpredicate. |
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§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).