(136 days)
Not Found
Not Found
No
The description focuses on the material and physical properties of a nerve cuff and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is described as a "flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury" and to "create a conduit for axonal growth across a nerve gap," which are therapeutic functions aimed at facilitating healing and growth.
No
The device is described as a "flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury" and "to create a conduit for axonal growth across a nerve gap." Its purpose is to facilitate healing and growth, not to diagnose a condition.
No
The device description clearly describes a physical, implantable medical device (a flexible tubular sheath) made of biomaterial, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity." This describes a surgical intervention and repair of tissue, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "flexible tubular sheath developed to provide a protective environment for peripheral nerve repair." This is a physical implant used during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device (biocompatibility, dimensions, compression, suture retention, shelf-life, simulated clinical environment), not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The SaluMedica™ Nerve Cuff with SalubriaTM Biomaterial is intendcd for use in repair of peripheral nerve discontinuities and where gap closure can be achieved by flexion of the extremity.
Product codes
JXI
Device Description
The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury.
The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap.
The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve
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
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Summary of Performance Studies
As part of the Pre-market Notification (510(k)) submission, non-clinical evaluation of the SaluMedica™ Nerve Cuff included the following:
- Biocompatibility Testing: Testing was completed to verify that the SaluMedica Nerve Cuff with Salubria Biomaterial has acceptable biocompatibility for use as a permanently implanted device.
- Dimensional Analysis: Dimensional analysis was completed to verify that the dimensions of the SaluMedica M Nerve Cuff were within specified tolerances following exposure to electron beam sterilization processing.
- Compression and Rebound Analysis: Compression and rebound analysis was completed to verify that the SaluMedica [M Nerve Cuff (1) can withstand compressive forces greater than 0.25N without collapsing, and (2) will re-open following removal of compressive forces sufficient to collapse the nerve cuff.
- Suture Retention Testing: Suture retention strength testing was completed to verify that the SaluMedica ?M Nerve Cuff has sufficient strength to resist suture pull-out under loads exceeding those anticipated in the intended use environment.
- Shelf-Life Testing: Accelcrated aging and testing was completed to verify maintenance of functional integrity of the SaluMedica™ Nerve Cuff following accelerated aging equivalent to six months of real-time aging.
- Evaluation of Nerve Cuff in a Simulated Clinical Environment: The SaluMedica™ Nerve Cuff was evaluated in the indicated covironment to demonstrate that the design of the device meets the needs of the user.
Key results: The device conforms to dimensional specifications, remains open during implantation even if compressed is capable of retaining suture material, and has a shelf life of six months based on accelerated aging testing. Further, evaluation of the SaluMedica Nerve Cuff in a Simulated Clinical Environment establishes that the device meets the needs of the patient and physician.
Key Metrics
Not Found
Predicate Device(s)
Currently no known FDA cleared nerve cuffs are available for commercial sale.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).
0
Køø2ø98
1. General information
- Correspondents to the File a. David Ku, M.D., Ph.D. President and CEO SaluMedica™
- Submitter's Name and Address b. SaluMedica™, L.L.C. 112 Krog Street Suite 4 Atlanta, Georgia 30307 Phone: (404) 589-1727 FAX: (404) 589-1737
- c. Device Generic Name Nerve Cuff
- Device Trade Name ਕੁੱਝ SaluMedicaTM Nerve Cuff
- Equivalent Devices e. Fastube™ Nerve Cuff and silicone nerve cuffs
2. Device Description
The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury.
The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap.
The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.
1
3. Intended Use
The SaluMedica™ Nerve Cuff with SalubriaTM Biomaterial is intendcd for use in repair of peripheral nerve discontinuities and where gap closure can be achieved by flexion of the extremity.
4. Non-Clinical Test Summary
Summary of Testing presented in 510(k)
As part of the Pre-market Notification (510(k)) submission, non-clinical evaluation of the SaluMedica™ Nerve Cuff included the following:
- Biocompatibility Testing a...
Testing was completed to verify that the SaluMedica Nerve Cuff with Salubria Biomaterial has acceptable biocompatibility for use as a permanently implanted device.
b. Dimensional Analysis
Dimensional analysis was completed to verify that the dimensions of the SaluMedica M Nerve Cuff were within specified tolerances following exposure to electron beam sterilization processing.
c. Compression and Rebound Analysis
Compression and rebound analysis was completed to verify that the SaluMedica [M Nerve Cuff (1) can withstand compressive forces greater than 0.25N without collapsing, and (2) will re-open following removal of compressive forces sufficient to collapse the nerve cuff.
d. Suture Retention Testing
Suture retention strength testing was completed to verify that the SaluMedica ?M Nerve Cuff has sufficient strength to resist suture pull-out under loads exceeding those anticipated in the intended use environment.
Shelf-Life Testing e.
Accelcrated aging and testing was completed to verify maintenance of functional integrity of the SaluMedica™ Nerve Cuff following accelerated aging equivalent to six months of real-time aging.
f. Evaluation of Nerve Cuff in a Simulated Clinical Environment The SaluMedica™ Nerve Cuff was evaluated in the indicated covironment to
demonstrate that the design of the device meets the needs of the user.
2
Currently no known FDA cleared nerve cuffs are available for commercial sale. Nonclinical evaluation as outlined above is intended to show that the SaluMedica Nerve Cuff meets the device design criteria based on the aide of information gained from medical professionals, literature reviews, and discussions with FDA reviewers. The device conforms to dimensional specifications, remains open during implantation even if compressed is capable of retaining suture material, and has a shelf life of six months based on accelerated aging testing. Further, evaluation of the SaluMedica Nerve Cuff in a Simulated Clinical Environment establishes that the device meets the needs of the patient and physician.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2000
David N. Ku, M.D., Ph.D. President and CEO Salumedica, L.L.C. 112 Krog Street, Suite 4 Atlanta, Georgia 30307
K002098 Re:
Trade Name: SaluMedica™ Nerve Cuff Regulatory Class: II Product Code: JXI Dated: September 22, 2000 Received: September 25, 2000
Dear Dr. Ku:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - David N. Ku, M.D., Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a promained from a classification for your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark n Milkenn
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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K002098 510(k) NUMBER:
SaluMedica™ Nerve Cuff DEVICE NAME:
INDICATIONS FOR USE:
Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format)
Mark N Milkman
for
(Division Sign-Off)
Division of General Restorative Devices 002098 510(k) Number _
A-1