(29 days)
VERSAPOINT* Electrosurgery System (SCUBA)
Not Found
No
The summary describes a material change to a component of an electrosurgical system and does not mention any AI or ML capabilities.
No.
The device is described as a "telescopic clip" which is a component of resectoscopic electrodes, designed to secure the distal portion of the electrode. This indicates it is an accessory or component part of a larger surgical system, rather than a standalone therapeutic device itself. Its function is mechanical (securing) rather than directly therapeutic.
No
The device description and intended use indicate that this device is used for cutting, removal, desiccation, excision, lysis, and incision of tissues, which are all therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "telescopic clip," which is a physical component made of Polypropylene or Polybutyleneterephthalate. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting, removal, and desiccation of tissue within the body (intrauterine). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device is a component of a resectoscopic electrode, designed to secure the electrode during a surgical procedure. This is consistent with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.
- Excision of intrauterine myomas -
- Excision of intrauterine polyps -
- Lysis of intrauterine adhesions -
- Incision of uterine septa
- Endometrial ablation
Product codes
HIH, HFI
Device Description
The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed The telescopic cup is a component stal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intrauterine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and bench testing have been performed to verify that the product meets the performance requirements described.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VERSAPOINT* Electrosurgery System (SCUBA)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.
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MAR - 9 2004
Attachment IV - 510(k) Summary
Statement:
Information supporting claims of substantial equivalence, as defined under the Federal Informanon supporting claims of substantial equivaness is summarized below.
Food, Drug, and Cosmetic Act, respecting safety and effectiveness with the Food, Drug, and Cosment Ass, respecting on mary is formatted in accordance with the Agency's final rule.
Modified Device Name: VERSAPOINT* Resectoscopic System
Predicate Device Name: VERSAPOINT* Electrosurgery System (SCUBA)
Device Description:
The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed The telescopie cup is a component stal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).
Indications for Use:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, frysteroscopic crocroourgeral prd benign conditions requiring endometrial ablation.
- Excision of intrauterine myomas -
- Excision of intrauterine polyps -
- Lysis of intrauterine adhesions -
- Incision of uterine septa -
- Endometrial ablation t
Technological Characteristics:
The modified device has the same technological characteristics as the predicate device. The only change to the device is to the material of the telescopic clip. The telescopic clip The only change to the ad with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).
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Performance Data:
Biocompatibility and bench testing have been performed to verify that the product meets the performance requirements described.
Conclusion:
Based upon the 510(k) summaries and 510(k) statements and the information provided Dascu upon the stocky outliners device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.
Contact:
Patricia M. Hojnoski Sr. Project Manager Regulatory Affairs Gynecare, A Division of Ethicon, Inc. P.O. Box 151, Route 22 West Somerville, NJ 08876
Date:
February 6, 2004
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Ms. Patricia M. Hojnoski Sr. Project Manager Regulatory Affairs Gynecare Worldwide A Division of ETHICON, Inc. U.S. Route 22 West P.O. Box 151 SOMERVILLE NJ 08876
Re: K040302 Trade/Device Name: VERSAPOINT* Resectoscope System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation Number: 21 CFR 884.4160 Regulation Name: Unipolar endoscopic coagulatorcutter and accessories Regulatory Class: II Product Code: 85 HIH and HFI Dated: February 6, 2004 Received: February 10, 2004
Dear Ms. Hojnoski:
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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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040302 _VERSAPOINT* Resectoscopic System __ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.
- Excision of intrauterine myomas -
- Excision of intrauterine polyps -
- Lysis of intrauterine adhesions -
- Incision of uterine septa
- Endometrial ablation
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadlon
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number .
000003