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

• K Number: K982891
• Device Name: CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
• Manufacturer: CALIFORNIA MEDICAL LABORATORIES, INC.
• Date Cleared: 1998-09-30 ( 44 days)
• Product Code: DTS
• Regulation Number: 870.4420
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: K053021

Intended Use

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

Device Description

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (suction wands), not an AI/ML device. Therefore, the typical acceptance criteria and study information requested for AI models (like performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable or present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary criterion for 510(k) clearance.

Here's a breakdown based on the provided text, addressing the points where possible and noting why others are not applicable:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria (Implicit for 510(k)): Substantial equivalence in intended use and technological characteristics to a legally marketed predicate device. Safety and effectiveness.
   • Reported Device Performance: The document states: "The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the predicate device." No specific performance metrics (like suction rate, material strength, etc.) are reported in this summary, as the focus is on equivalence rather than novel performance claims.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. This is a medical device clearance, not an AI/ML study. There isn't a "test set" in the context of data for an algorithm. Device testing would likely involve bench testing or possibly limited clinical testing to support safety and performance, but the details are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable in the AI/ML sense. For a physical medical device like this, "ground truth" relates to engineering specifications, material properties, and functional performance benchmarks, often established through standards, predicate device characteristics, and internal testing. No specific "ground truth" data is detailed for analysis in this document.

8. The sample size for the training set

   • Not Applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not Applicable. This is not an AI/ML device.

Additional Information from the Document:

• Intended Use: To remove excess fluid from the surgical field.
• Predicate Device: Research Medical, Inc. Rigid Intracardiac Suction Wand.
• Basis of Equivalence: "The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the Research Medical predicate device."
• Device Description:
  • Consists of an angled Stainless Steel suction wand, a fluted style suction tip (ABS) at the distal end, and a ¼" barbed connector (ABS) at the proximal end.
  • Has a lightweight plastic handle made of medical grade ABS material.
  • Two sizes: Standard and Small.
• Regulatory Class: II
• Product Code: DTS

Summary

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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

'

510(k) Number

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

Regulation Number and Section

§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.

(a)
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.(b)
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.