(86 days)
Not Found
Not Found
No
The device description focuses on the mechanical and electrical components of a sheath for electrosurgical procedures and does not mention any AI or ML capabilities.
No
The device is described as an accessory (sheath) for resectoscopes used during surgical procedures to resect and/or ablate uterine tissue, and it acts as an electrical return. It facilitates a medical procedure but does not directly deliver a therapeutic effect itself.
No.
The device is indicated for use during the resection and/or ablation of unwanted or diseased uterine tissue, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components (tubular sheath, electrode, conductor, wire connector lead, insulating outer jacket) and its function as a physical accessory to a resectoscope, indicating it is a hardware device.
Based on the provided information, the ERA Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "resection and/or ablation of unwanted or diseased uterine tissue." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "tubular sheath device incorporating an electrosurgical return electrode" designed to fit over a resectoscope for surgical procedures.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. The ERA Sheath is used inside the body during a surgical procedure.
The device is clearly intended for surgical intervention and not for the analysis of biological samples in a laboratory setting, which is the hallmark of an IVD.
N/A
Intended Use / Indications for Use
The ERA Sheath is indicated for use during the resection or ablation of unwanted or diseased uterine tissue.
The ERA Sheath is indicated for use during resection and/or ablation of unwanted or diseased uterine tissue.
Product codes
85 HIH
Device Description
The ERA Sheath is a tubular sheath device incorporating an electrosurgical return electrode. The Sheath is designed to fit over the shaft of a standard gynecological resectoscope to act as an electrical return, thereby, obviating the need for an electrosurgical dispersive pad. The design of the Sheath enables a uterine tissue resection or ablation procedure to be performed in isotonic solution instead of hypotonic solutions which are currently used in these procedures, thereby eliminating the risk of hyponatremia.
The ERA Sheath is composed of four structural elements: 1) a non-conductive sheath material which is placed over a standard continuous flow resectoscope, 2) a return electrode located on the distal end of the sheath with a conductor that runs along the sheath's surface to the proximal end of the sheath, 3) a standard wire connector lead which is used to attach the sheath to the return/patient outlet on the electrosurgical generator, and 4) an insulating outer jacket which is configured to expose the distal electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine tissue
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
Results from clinical evaluations, electrical safety testing, and histopathological evaluation of extirpated uterine tissue resected/ablated with the sheath were supplied in support of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
the Gynecare VersaPoint System, the FemRx PEARL Loop/OPERA System, the Karl Storz Continuous Flow Resectoscope, and the Conceptus FUTURA Sheath for Urological indications.
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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K972210 page 1/2
ATTACHMENT C
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter's Name, Address, Telephone Number
Conceptus, Inc. 1021 Howard Ave. San Carlos, CA 94070 (415) 802-7240
Contact Person
Cindy Domecus Senior Vice President Clinical Research, Regulatory Affairs, and Quality Assurance
Date of Summary
September 3, 1997
Device Names
Trade Name: ERA Sheath Common Name: Resectoscope Sheath with Return Electrode Classification Name: Hysteroscope and Accessories
Device to Which Substantial Equivalence was Claimed
Substantial Equivalence was claimed to the Gynecare VersaPoint System, the FemRx PEARL Loop/OPERA System, the Karl Storz Continuous Flow Resectoscope, and the Conceptus FUTURA Sheath for Urological indications.
Device Description
The ERA Sheath is a tubular sheath device incorporating an electrosurgical return electrode. The Sheath is designed to fit over the shaft of a standard gynecological resectoscope to act as an electrical return, thereby, obviating the need for an electrosurgical dispersive pad. The design of the Sheath enables a uterine tissue resection or ablation procedure to be performed in isotonic solution instead of hypotonic solutions which are currently used in these procedures, thereby eliminating the risk of hyponatremia.
1
The ERA Sheath is composed of four structural elements: 1) a non-conductive sheath material which is placed over a standard continuous flow resectoscope, 2) a return electrode located on the distal end of the sheath with a conductor that runs along the sheath's surface to the proximal end of the sheath, 3) a standard wire connector lead which is used to attach the sheath to the return/patient outlet on the electrosurgical generator, and 4) an insulating outer jacket which is configured to expose the distal electrodes.
Intended Use
The ERA Sheath is indicated for use during the resection or ablation of unwanted or diseased uterine tissue.
Data Supporting Substantial Equivalence
Results from clinical evaluations, electrical safety testing, and histopathological evaluation of extirpated uterine tissue resected/ablated with the sheath were supplied in support of substantial equivalence.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle's head and three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Ms. Cindy Domecus Senior Vice President Clinical Research, Regulatory Affairs, and Quality Assurance .. Conceptus, Inc. 1021 Howard Avenue San Carlos, California 94070
Re: K972210 ERA Resectoscope Sheath Dated: June 9 . 1997 - ..... Received: June 11, 1997 Regulatory class: II 21 CFR §884.1690/Product code: 85 HIH
Dear Ms. Domecus:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 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 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 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/cdrh/dsmamain.html".
Sincerely yours.
h7liau Yi
Lillian Yin, Ph.D.
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
3
Page_1_of_ I
510(k) Number (if known): K972210
ERA Sheath Device Name:_
Indications For Use:
や
The ERA Sheath is indicated for use during resection and/or ablation of unwanted or diseased uterine tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
Polar
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972210
Prescription (jse_L/ (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)