(55 days)
Not Found
No
The summary describes a mechanical device (a blade that mounts to an endoscope) and makes no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No.
The device cuts tissue, which is a surgical procedure, not a therapeutic treatment.
No
The provided text describes a surgical device used for minimally invasive procedures, not a device used for diagnosing conditions.
No
The device description explicitly states it is a "device that mounts to a 4mm 30° endoscope," indicating it is a physical component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a surgical tool used directly on the patient's body during minimally invasive procedures to cut ligaments or fascia. It does not involve the analysis of specimens taken from the body.
Therefore, the Mountable Endoscopic Blade falls under the category of a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.
- Carpal tunnel release for carpal tunnel syndrome .
- Plantar fasciotomy for plantar fasciitis .
- Lateral release of the knee for extensor mechanism malalignment .
- Forearm fasciotomy for compartment syndrome
- . Morton's neuroma for interdigital neuroma
- Gastrocnemius release for heel cord contracture (equinus) .
Product codes
EMF
Device Description
The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ligament or fascia, Carpal tunnel, Plantar fascia, knee, forearm, interdigital, heel cord
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of AM Surgical's Mountable Endoscopic Blade.
| Submitted By: | A.M. Surgical, Inc. |
|---|---|
| Date: | January 14, 2008 |
| Contact Person: | Vincent Pascale |
| Phone: 800-437-9653 | |
| Fax: 631-980-4369 | |
| Proprietary Name: | Mountable Endoscopic Blade |
| Common Name: | Surgical Knife |
| Classification Name and Reference: | 21 CFR 878.4800, Manual Surgical Instrument |
| for General Use | |
| Device Product Code and Panel Code: | General and Plastic Surgery/EMF |
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.
- Carpal tunnel release for carpal tunnel syndrome .
- Plantar fasciotomy for plantar fasciitis .
- Lateral release of the knee for extensor mechanism malalignment .
- Forearm fasciotomy for compartment syndrome
- . Morton's neuroma for interdigital neuroma
- Gastrocnemius release for heel cord contracture (equinus) .
DEVICE DESCRIPTION B.
The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.
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Ko 80133
Page 2 of 2
C. MATERIALS
The blade is manufactured from stainless steel. There is no change in material for the Mountable Endoscopic Blade.
SUBSTANTIAL EQUIVALENCE INFORMATION D.
The intended use, material composition, and design features of the Mountable Endoscopic Blade are substantially equivalent to previously cleared 510(k) Mountable Endoscopic Blade (K982142). The safety and effectiveness of Mountable Endoscopic Blade is adequately supported by the substantial equivalence information provided within this Premarket Notification.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
A.M. Surgical, Inc. % Mr. Vincent Pascale 290 East Main Street, Suite 200 Smithtown, New York 11787
Re: K080133
Trade/Device Name: Mountable Endoscopic Blade Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: EMF Dated: March 5, 2008 Received: March 5, 2008
Dear Mr. Pascale:
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 - Mr. Vincent Pascale
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko80133
Indications for Use Statement
510(k) Number: Not yet assigned.
Device Name: Mountable Endoscopic Blade
Indications For Use:
The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.
- · Carpal tunnel release for carpal tunnel syndrome
- · Plantar fasciotomy for plantar fasciitis
- · Lateral release of the knee for extensor mechanism malalignment
- · Forearm fasciotomy for compartment syndrome
- · Morton's neuroma for interdigital neuroma
- · Gastrocnemius release for heel cord contracture (equinus)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
Prescription Use _
OR
Over-The Counter Use
(Optional Format 1-2-
(Per21 CFR 801.109) તેર)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Rl Oglin for mxn
Division of General, Restorative. and Neurological Devices
510(k) Number. K080133