(112 days)
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI/ML terms or functionalities.
No
The device is described as a suturing device intended for securing spinal cord stimulation leads, which are used for therapy, but the device itself is a mechanical anchor/suture, not directly providing therapy or diagnosis.
No
The device is described as a suturing device used to secure leads and catheters, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components made of carbon fiber reinforced PEEK and suture material, delivered via a needle-tipped device. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The A.I.M. Lead Loop Suturing Device is a surgical implant used to secure medical leads and catheters within the body. It is a mechanical device used for fixation, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for "securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament." This is a surgical procedure, not a diagnostic test.
The description and intended use of the device clearly indicate it is a surgical implant and fixation device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
GZB, GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fascia or intra-spinous/supra-spinous 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
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.
The A.I.M. Lead Loop Suturing Device was determined to be biocompatible based on conformity with ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
Boston Scientific Fixate Suturing Device (K113805)
Reference Device(s)
A.I.M Knotless Meniscal Repair Device (K133770), Suture Anchor (K132461)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 Lane
Suite 308
Rockville, 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 in |
| securing Spinal Cord Stimulation (SCS) leads and catheters to the | |
| fascia or intra-spinous/supra-spinous ligament. | |
| Device Description: | 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. | |
| Substantial Equivalence | |
| Summary: | The A.I.M. Lead Loop Suturing Device is substantially equivalent |
| to the cited predicate, Boston Scientific's Fixate Suturing Device, | |
| having the same, or similar, intended use, indications for use, and | |
| fundamental scientific technology. | |
| The A.I.M Lead Loop Suturing Device and predicate differ in | |
| suture anchor count, the means of tensioning and capturing the | |
| SCS lead anchor or catheter, and retaining tension. | |
| Comparative performance testing with the predicate demonstrated | |
| equivalent performance and did not raise any new questions of | |
| safety or effectiveness. | |
| Performance Testing: | 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. | |
| Safety Testing: | The A.I.M. Lead Loop Suturing Device was determined to be |
| biocompatible based on conformity with ISO 10993. Component | |
| materials and assembly processes are identical or similar to those | |
| utilized within the A.I.M Knotless Meniscal Repair Device | |
| (K133770) and Suture Anchor (K132461). | |
| Conclusion: | Based on the similarity in intended use, materials, fundamental |
| scientific technology and performance testing, the A.I.M. Lead | |
| Loop Suturing Device is substantially equivalent to the cited | |
| predicate. |
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