(88 days)
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No
The 510(k) summary describes a simple laparoscopic hand instrument and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as a "Laparoscopic Hand Instrument" used for blotting and sponging tissue, which are surgical assistance functions rather than direct therapeutic actions to treat a disease or condition.
No
The device, a laparoscopic hand instrument, is described for use in surgical procedures to blot small bleeders and sponge tissue. This is an assistive tool for surgical manipulation, not for identifying the nature or cause of disease.
No
The device description explicitly states it is a "Laparoscopic Hand Instrument," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used during a laparoscopic procedure to physically interact with tissue (blotting and sponging). This is a direct interaction with the body, not an analysis of samples taken from the body.
- Device Description: It's described as a "Laparoscopic Hand Instrument," which is consistent with a surgical tool.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue samples, etc.), chemical reactions, or diagnostic testing performed outside the body.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Christoudias Gauze Dissector does not fit this description.
N/A
Intended Use / Indications for Use
The Christoudias Gauze Dissector is indicated for laparoscopic general surgical procedures where blotting small bleeders and/or sponging tissue in a visible, atraumatic would be advantageous.
Product codes
85 HET
Device Description
Christoudias Gauze Dissector (Laparoscopic Hand Instrument)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the United States Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the caduceus in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1998
Mr. Frank Lewis President InnerVision®, Inc. 6258 Shady Grove Road E. Memphis, TN 38120
Re: K982428
Christoudias Gauze Dissector (Laparoscopic Hand Instrument) Dated: June 15, 1998 Received: July 13, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
Dear Mr. Lewis:
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 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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.
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) 594-4613. 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/cdrb/dsmaldsmam.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1 - 1
510[k] Number (if known): _ K982428
Device Name: Christoudias Gauze Dissector (Laparoscopic Hand Instrument)
Indications for Use:
The Christoudias Gauze Dissector is indicated for laparoscopic general surgical procedures where blotting small bleeders and/or sponging tissue in a visible, atraumatic world be advantageous.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
ivision Sign-Off) vision of Reproductive, Abdominal, ENT, 1 Radiological Device 8987.428 (k) Mimber. Ch.
OR
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)