(27 days)
Not Found
No
The description details a simple electrical cord for transmitting RF power, with no mention of computational processing, algorithms, or learning capabilities.
No
This device is an accessory (bipolar cord) that transmits RF power from an electrosurgery unit to a resectoscope electrode. While the overall system it's part of (resectoscope and ESU) performs therapeutic functions, the cord itself is a passive conductor and not a therapeutic device.
No
The device is described as a disposable bipolar cord that transmits RF power from an electrosurgery unit to a resectoscope electrode. Its function is to facilitate the conductive transmission of power for surgical procedures, not to diagnose medical conditions.
No
The device description clearly details physical components like a cord, connectors, wires, and insulating jackets, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a cord that transmits RF power from an electrosurgery unit to an electrode used in a resectoscope. This is a surgical accessory used during a procedure, not for analyzing samples outside the body.
- Intended Use: The intended use is to connect components of a surgical system to transmit power for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical accessory or component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.
Product codes
HIH, HGI
Device Description
The ACMI Bipolar Disposable Cord, Catalogue # DBC, interconnects electrosurgical unit (ESU) (source of RF power) to the Electrode that is inserted into the Bipolar Resectoscope Working Element. It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode.
The Bipolar Disposable Cord is a component or accessory of the ACMI Bipolar Resectoscope System. It is sold as a sterile, single use disposable device. The Bipolar Disposable Cord consists of the following:
a. Cord: containing a twisted wire pair that transmits power from the proximal two-pin connector to contacts in the distal molded connector part. The cable is shielded within an outer insulating jacket.
b. Distal Connector: Two "c-spring" contacts with polyurethane over-mold and "T" shaped strain relief. The distal connector contacts the electrode, which is inserted into the Resectoscope Working Element.
c. Proximal Connector: Two-pin (female) connector over-molded with polyvinyl chloride strain relief.
This Special 510(k) proposes a modification in the design, performance, dimensional, and materials specifications for Disposable Bipolar Cord. The indications for use, principles of operation, the packaging materials, and the sterilization parameters of the Disposable Binolar Cord remain the same as in the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
ACMI Disposable Bipolar Cord ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772
AUG 2 2 2002
Special 510(k) Notificatio Summary of Safety and Effectiveness July 26, 2002
K022480
Page 1 of 2
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI DISPOSABLE BIPOLAR CORD
General Information
Manufacturer:
ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
9920160
July 26, 2002
John A. DeLucia VP. Ouality Assurance, Regulatory Affairs and Clinical Affairs
Date Prepared:
Contact Person:
Device Description
Classification Name:
Endoscope and accessories (21CFR 876.1500) Gynecologic Electrocautery and Accessories (21CFR 884.4120)
Trade Name:
ACMI Disposable Bipolar Cord
Generic/Common Name:
Predicate Devices
ACMI Disposable Active Cord
Preamendment & K890328
Endoscope and accessories
Intended Uses
The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element (WE) to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.
1
Special 510(k) Notification Summary of Safety and July 26, 2002
K022480
Page 2 of 2
Product Description
The ACMI Bipolar Disposable Cord, Catalogue # DBC, interconnects electrosurgical unit (ESU) (source of RF power) to the Electrode that is inserted into the Bipolar Resectoscope Working Element. It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode.
The Bipolar Disposable Cord is a component or accessory of the ACMI Bipolar Resectoscope System. It is sold as a sterile, single use disposable device. The Bipolar Disposable Cord consists of the following:
a. Cord: containing a twisted wire pair that transmits power from the proximal two-pin connector to contacts in the distal molded connector part. The cable is shielded within an outer insulating jacket.
b. Distal Connector: Two "c-spring" contacts with polyurethane over-mold and "T" shaped strain relief. The distal connector contacts the electrode, which is inserted into the Resectoscope Working Element.
c. Proximal Connector: Two-pin (female) connector over-molded with polyvinyl chloride strain relief.
This Special 510(k) proposes a modification in the design, performance, dimensional, and materials specifications for Disposable Bipolar Cord. The indications for use, principles of operation, the packaging materials, and the sterilization parameters of the Disposable Binolar Cord remain the same as in the predicate device.
Summary of Safety and Effectiveness
The proposed modifications for the Disposable Bipolar Cord, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, dimensional specifications, and materials specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
AUG 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John A. DeLucia Vice President, Quality Assurance, Regulatory Affairs, Clinical Affairs ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104
Re: K022480
Trade/Device Name: ACMI Disposable Bipolar Cord Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Regulation Number: 21 CFR §884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: 85 HGI Dated: July 26, 2002 Received: July 26, 2002
Dear Mr. DeLucia:
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); 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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 Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ACMI Disposable Bipolar Cord ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Statement of Intended Use July 26, 2002
Device Name: ACMI Disposable Bipolar Cord
510(k) Number: K022480
Indications for use:
The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
Nancy C. Broadon
of Renmonu 510kl N