CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS

K982891 · California Medical Laboratories, Inc. · DTS · Sep 30, 1998 · Cardiovascular

Device Facts

• Record ID: K982891
• Device Name: CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
• Applicant: California Medical Laboratories, Inc.
• Product Code: DTS · Cardiovascular
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4420
• Device Class: Class 2

Intended Use

The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.

Device Story

Standard and Small Rigid Tip Suction Wands are manual surgical instruments used to remove excess fluid from the surgical field. The device consists of an angled stainless steel suction wand, a rigid fluted suction tip, and a 1/4" barbed connector. The handle and connector are constructed from medical-grade ABS plastic. The device is intended for use by clinicians in a surgical setting. It functions as a passive conduit for suction, connecting to external hospital suction systems to clear fluids, thereby maintaining visibility and a clean surgical site for the surgeon.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Stainless steel wand, medical-grade ABS plastic handle and connector. Design: Angled wand with rigid, fluted suction tip and 1/4" barbed proximal connector. Operation: Passive suction instrument; no energy source or software.

Indications for Use

Indicated for removal of excess fluid from the surgical field during surgical procedures.

Regulatory Classification

Identification

A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.

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 the limitations in § 870.9.

Predicate Devices

• Research Medical, Inc. Rigid Intracardiac Suction Wand

Submission Summary (Full Text)

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# K982841

# Summary of Safety and Effectiveness

#### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The California Medical Laboratories. Inc. devices are substantially equivalent to the Research Medical predicate device. The California Medical Laboratories, Inc. devices have substantially equivalent intended uses as the predicate device. The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the Research Medical predicate device.

#### COMPANY AND CONTACT PERSON

California Medical Laboratories Inc. 2681 Kelvin Avenue Irvine, California 92614

Mehmet Bicakci President

### DEVICE NAME

California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wand

#### NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

The claim of substantial equivalence is based upon the following device:

- Research Medical, Inc. Rigid Intracardiac Suction Wand .
# DESCRIPTION OF DEVICE

The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.

The Standard Rigid Tip Suction Wand consists of an angled Stainless Steel suction wand bonded to a rigid, fluted style suction tip at the distal end and a ¼" barbed connector at the proximal end both of which are made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material.

The Small Rigid Tip Suction Wand is manufactured in a similar manner and consisting of the same materials as the Standard Rigid Tip Suction Wand.

## STATEMENT OF INTENDED USE

The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.

### STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

The predicate device has the same intended use as stated above.

# STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE

The California Medical Laboratories, Inc devices have technologic characteristics, which are substantially equivalent to the predicate device.

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUM SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Mr. Mehmet Bicakci President California Medical Laboratories, Inc. 2681 Kelvin Avenue Irvine, California 92614

Re: K982891 Trade Name: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wand Regulatory Class: II Product Code: DTS Dated: August 14, 1998 Received: August 17, 1998

Dear Mr. Bicakci:

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 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 (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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set torth 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 requlatory 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 - Mr. Mehmet Bicakci

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 leqally 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 [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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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510(k) Number (if known):

K982891

California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Device Name: Wands

Indications

For Use:

The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.

# Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K982891

**Prescription Use**
Per 21 CFR 801.109

Over-The-Counter Use _ OR

(Division Sign-Off)
Division of General Restorative Devices
(reg.) Number 15982891

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510(k) Number

510(k) Notification California Medical Laboratories, Inc. CONFIDENTIAL 8/9/1998