CHASE ANASTOMOSIS VISUALIZATION DEVICE

K974568 · Chase Medical, Inc. · FQH · Jan 6, 1998 · General Hospital

Device Facts

• Record ID: K974568
• Device Name: CHASE ANASTOMOSIS VISUALIZATION DEVICE
• Applicant: Chase Medical, Inc.
• Product Code: FQH · General Hospital
• Decision Date: Jan 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2

Intended Use

The Chase Anastomosis Visualization Device is indicated for use during procedures wherein clearing of a wound or surgical site, for enhanced visibility, must be maintained by non-contact means.

Device Story

Device is a malleable wand used during surgery to clear wound or surgical sites for enhanced visibility via non-contact means. Input consists of regulated gas and fluid from a standard administration set. Device transforms these inputs into a fan-shaped irrigation mist pattern at the distal tip. Wand features embedded stainless steel wire for shape retention, a 0.2-micron hydrophobic bacterial filter, and a fluid inlet line with luer-lock adaptor. Operated by clinicians in a surgical setting. Output is a mist spray that clears the site, allowing the surgeon to maintain a clear view of the operative field. Benefits include improved visualization during anastomosis or other surgical procedures.

Clinical Evidence

Bench testing only. Testing included leak testing at 10 psi, tubing bond strength (>10 lb tensile), package integrity (Tyvek/Polymylar burst test per ASTM F1140-88), and shipping/distribution vibration and drop tests per National Safe Transit Association standards. Accelerated aging confirmed a two-year shelf life.

Technological Characteristics

Malleable wand (approx. 10.125 inches) with embedded stainless steel wire for shape retention. Includes 0.2-micron hydrophobic medical-grade in-line bacterial filter and 1/4-inch PVC tubing. Distal tip provides fan-shaped irrigation mist. Fluid inlet uses female luer-lock adaptor. Sterilized via Ethylene Oxide (Overkill Method, SAL 10^-6).

Indications for Use

Indicated for use during surgical procedures requiring non-contact clearing of a wound or surgical site to enhance visibility.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• RMI Surgical Site Visualization Wand

Submission Summary (Full Text)

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K974568

# SUMMARY OF SAFETY AND EFFECTIVENESS

JAN - 6 1900

# CHASE ANASTOMOSIS VISUALIZATION DEVICE

#### General Information I.

| A. Generic Name: | Anastomosis Visualization Device |
|------------------------------------|----------------------------------------|
| B. Trade Name of Device: | CHASE Anastomosis Visualization Device |
| C. Applicant's Name and Address: | CHASE MEDICAL INC. , Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |

- Indication for Use: II.
The Chase Anastomosis Visualization Device is indicated for use during procedures wherein clearing of a wound or surgical site, for enhanced visibility, must be maintained by non-contact means.

- III. Device Description
The Chase Anastomosis Visualization Device consists of a malleable wand, a 0.2 micron filter, and a sterile fluid inlet line. The overall length of the wand is approximately 10.125 inches in length. The stainless steel wire is completely embedded within the wall along its length for the purpose of maintaining a user chosen shape. The distal tip is designed to provide a fan-shaped irreigation mist pattern. The remaining proximal length of the wand is the regulated gas inlet which consists of a 0.2 micron medical grade in-line bacterial filter made of a hydrophobic membrane and a 1/4 inch tubing connecter. A 1/4 inch PVC tube which connects the in-line filter to the regulated gas source. A fluid inlet line extends from a point near the proximal end of the malleable section of the wand and terminates in a female luer-lock adaptor for conneciton to a standard fluid administration set which provides for flow control and on-off capacity

- IV. Device Classification: Class II device
- V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the RMI Surgical Site Visualization Wand.

- VI. Other Safety and Effectiveness Data:
All material are identical to the predicate device. Materials: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) Sterilization: SAL - 10*

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# SUMMARY OF SAFETY AND EFFECTIVENESS

### Functional Testing

All functional characteristics of the Chase Medical Anastomosis Visualization Device are nondifferentiable as compared with the predicate.

| Leak Test Requirements: | No leaks at 10 psi air on Chase device |
|----------------------------------|------------------------------------------------------------|
| Tubing Bond Strength: | Exceeds 10 lb. tensile strength |
| Package Integrity: | Tyvek/Polymylar passed burst test per ASTM<br>F1140-88 |
| Shipping & Distribution Testing: | Per National Safe Transit Ass. vibration and<br>drop tests |
| Accelerated Aging: | Two year shelf life |

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bert Davis ·President Chase Medical, Incorporated 1876 Firman Drive 75081 Richardson, Texas

JAN - 6 1998

Re : K974568 Chase Anastomosis Visualization Device Trade Name: Requlatory Class: II Product Code: FMQ Dated: November 24, 1997 Received: December 5, 1997

Dear Mr. Davis:

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 provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Davis

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974568

# CHASE MEDICAL INC.

# ANASTOMOSIS VISUALIZATION DEVICE

Indications For Use: ***

The Chase Anastomosis Visualization Device is indicated for use during procedures wherein clearing of a wound or surgical site, for enhanced visibility, must be maintained by non-contact means.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR Over-The-Counter Use_ Prescription Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)