(555 days)
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Not Found
No
The summary describes a surgical scalpel and delivery system, with no mention of AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for cutting and coagulation of soft tissues, which are therapeutic medical interventions.
No
The device is described as a scalpel system used for cutting and coagulation of soft tissues, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states "Dual Hook Scalpel (fiberoptic delivery system)", indicating a physical hardware component for cutting and coagulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, and coagulation of soft tissues encountered in general surgical applications." This describes a surgical tool used directly on the patient's body.
- Device Description: The description "Dual Hook Scalpel (fiberoptic delivery system)" further reinforces that it's a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the Dual Hook Scalpel is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgical applications. This includes incision, excision, or coagulation of tissue.
Product codes
GEX
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
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are 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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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 stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Innovative Healthcare Devices, Inc. c/o Mr. Wayne Dillender 4675 Cornell Road, Suite 180 Cincinnati, Ohio 45241
Re: K970069
Trade Name: Dual Hook Scalpel (Fiber Optic Delivery System) Regulatory Class: II Product Code: GEX Dated: May 1, 1998 Received: May 1, 1998
Dear Mr. Dillender:
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 (OS) 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.
1
Page 2 - Mr. Wayne Dillender
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 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 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
K970069
Device name:
・
Dual Hook Scalpel (fiberoptic delivery system)
r →
Indications for Use:
The Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgical applications. This includes incision, excision, or coagulation of tissue.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
---|---|---|---|
------------------------------------------ | ----------------------------------------- | ---- | ---------------------- |
(Division Sign-Off) | |
---|---|
--------------------- | -- |
Division of General Restorative Devices | |
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510(k) Number | K970069 |
(Optional Format 1-2-96) | |
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-- | -------------------------- |
PAGE 009Concurrence of CDRH, Office of Device Evaluation (ODE)