(211 days)
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Not Found
No
The 510(k) summary describes a mechanical surgical safety scalpel with no mention of software, data processing, or AI/ML terms.
No
The device is described as a cutting device for surgical, pathology, and minor medical procedures, and its primary purpose is to protect against accidental injuries. It does not state that it treats or ameliorates a disease or condition.
No
Explanation: The device is described as a "surgical safety scalpel intended for use as a cutting device" and for "protection against accidental injuries," which indicates it is an surgical instrument, not a diagnostic tool.
No
The device is described as a "surgical safety scalpel," which is a physical cutting instrument, not software.
Based on the provided information, the Spectra Safety Scalpel is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "cutting device during surgical, pathology and minor medical procedures." This describes a device used on a patient or for procedures directly involving tissue manipulation, not for testing samples outside the body to diagnose conditions.
- Lack of IVD Characteristics: The description doesn't mention anything about analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. IVDs are designed to perform tests on these samples.
Therefore, the Spectra Safety Scalpel falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.
Product codes
GDZ, GES
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling the image of an eagle. The eagle is stylized with three overlapping profiles, symbolizing the department's focus on health, human services, and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Spectra Medical Devices, Inc. % Mr. Agustin Turriza 260 F&H Fordham Road Wilmington, Massachusetts 01887
DEC 1 5 2009
Re: K091462
Trade/Device Name: Spectra Medical Safety Scalpel Regulation Number: 21 CFR 878-4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: GDZ, GES Dated: December 09, 2009 Received: December 09, 2009
Dear Mr. Turriza:
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 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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Page 2 - Mr. Agustin Turriza
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification Submission: SPECTRA SAFETY SCALPEL
Indications For Use
510(k) Number (if known):
Device Name: SPECTRA SAFETY SCALPEL
Indications For Use:
The Spectra Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nathrepell firman
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091462