ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC

K022480 · Acmi Corporation · HIH · Aug 22, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022480
• Device Name: ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
• Applicant: Acmi Corporation
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

ACMI Disposable Bipolar Cord serves as conductive interface between electrosurgical unit (ESU) and bipolar resectoscope electrode; transmits RF power for electrosurgery. Device consists of twisted wire pair, shielded cable, distal 'c-spring' contacts with polyurethane over-mold, and proximal two-pin female connector with PVC strain relief. Used in clinical settings by medical professionals during resectoscope procedures. Sterile, single-use disposable design. Modifications to predicate include updated design, performance, dimensional, and material specifications.

Clinical Evidence

bench testing only

Technological Characteristics

Twisted wire pair cable with outer insulating jacket; distal 'c-spring' contacts with polyurethane over-mold; proximal two-pin female connector with polyvinyl chloride strain relief. Conductive transmission of RF power. Sterile, single-use.

Indications for Use

Indicated for use as a conductive accessory to connect an electrosurgical unit to a resectoscope electrode for transmission of RF power during electrosurgical procedures.

Regulatory Classification

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.

Predicate Devices

• ACMI Disposable Active Cord (K890328)

Submission Summary (Full Text)

{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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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