The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomitous or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.

Device Description

The device uses conventional technology to provide medical suction. The mechanical portion of the aspirator consists of an electrically driven pump to provide suction, a gauge to indicate the suction level and a regulator to control the suction level.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the care-e-vac 3 device:

Based on the provided information, the care-e-vac 3 is a medical suction device, and its 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Care-E-Vac II) rather than presenting a detailed clinical study with specific performance metrics against an acceptance criterion in the way a diagnostic device might.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted as they are not applicable to this type of submission.

Here's what can be inferred and stated based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness Equivalent to Predicate Device (K926566 - Care-E-Vac II)	The care-e-vac 3 is as safe, as effective, and performs as well as the predicate device.
Compliance with Voluntary Standards	The care-e-vac 3 complies with the voluntary standards as detailed in Section 9 of the submission (details of these standards are not provided in the extract).
Maintains Intended Use of Predicate Device	The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation. The intended use has not changed as a result of changes to the care-e-vac 3.
Functional Technology is Similar to Predicate Device	The care-e-vac 3 employs the same functional technology as the predicate device.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission describes a "Test Summary" indicating compliance with voluntary standards, but it does not mention a clinical study with a test set of patient data. The evaluation appears to be based on technical performance and comparison to a predicate device, likely through engineering testing rather than clinical data.
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. No ground truth for a clinical test set is mentioned, as there is no described clinical study in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication method is described.
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
- No such study was done. This device is a mechanical medical suction device, not an AI-powered diagnostic or assistive technology for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this type of device and submission, the "ground truth" for performance would be adherence to engineering specifications and equivalence to the predicate device's established performance, rather than clinical outcomes or diagnostic accuracy.
The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.
How the ground truth for the training set was established
- Not Applicable. There is no mention of a training set.

Summary of the nature of the study presented:

The information primarily describes a 510(k) submission for a Class II medical device (portable aspirator) that uses substantial equivalence as its regulatory pathway. The "study" mentioned is a "Test Summary" indicating that the device "complies with the voluntary standards" and that "The results of these measurements demonstrated that the care-e-vac 3 is as safe, as effective, and performs as well as the predicate device." This suggests engineering and performance testing against agreed-upon standards and direct comparison with the predicate device, rather than a clinical trial involving patient data and statistical metrics typically used for diagnostic or therapeutic efficacy claims.

Summary

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K062610

510(k) Summary of Safety and Effectiveness

Date:	June 5, 2006	SEP 2 8 2006
Submitter:	Ohio Medical Corporation1111 Lakeside DriveGurnee, IL 60031
Contact Person:	Hoby ChaeDirector of Engineering & QualityOhio Medical Corporation847-855-6272847-855-6304 (fax)
Device:	Trade Name:	care-e-vac 3
Common/Usual Name:	Portable medical suction device
Classification Names:
CFR Reference:	21CFR878.4780
Classification Name:	Pump, Portable, Aspiration
Product Code:	BTA
Predicate Device:	K926566 - Care-E-Vac II
Device Description:	The device uses conventional technology to provide medical suction.The mechanical portion of the aspirator consists of an electrically drivenpump to provide suction, a gauge to indicate the suction level and aregulator to control the suction level.
Intended Use:	The device is a portable aspirator which uses suction as a means towithdraw fluids or foreign bodies from a patient. The primary intendeduse of the care-e-vac 3 is as an aspirator to be used to help evacuatesaliva, mucous, vomitous or other aspirant from the mouth and orairway to allow adequate respiration or ventilation of the patient.
Technology:	The care-e-vac 3 employs the same functional technology as thepredicate device.
Test Summary:	The care-e-vac 3 complies with the voluntary standards as detailed inSection 9 of this submission.
Conclusion:	The results of these measurements demonstrated that the care-e-vac 3is as safe, as effective, and performs as well as the predicate device.

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Section 3 Proposed Labeling

3.1 Intended Use

The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.

The intended use has not changed as a result of changes to the care-e-vac 3.

3.2 Proposed Operating Instructions

Refer to Appendix A for a copy of changes made to the care-e-vac 3 Operator's Manual due to the device modifications contained in this release.

3.3 Promotional Material / Specification Sheet

A draft promotional brochure / specification sheet for the care-e-vac 3 can be found in Appendix B.

3.4 Device and Package Labeling

Draft device and package labeling for the care-e-vac 3 can be found in Appendix E.

Reference the following documents:

	Appendix
Operating Instructions	A
Promotional Brochure / Specification Sheet	B
Label - Example	E

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

Mr. Hoby Chae Director of Engineering and Quality Ohio Medical Corporation 1111 Lakeside Drive Gurnee, Illinois 60031

Re: K062610

Trade/Device Name: CARE-E-VAC 3 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II · Product Code: BTA Dated: August 30, 2006 Received: September 5, 2006

Dear Mr. Chae:

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 such 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 Eederal Register.

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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.

This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syndie Y. Michael Davis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): TBD

Device Name: care-e-vac 3

Indications For Use:

The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the caree-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

...sion Sign-Off)
sion of Anesthesiology, General Hospital,
Distol Devices

ion of Anesthoundains of Devices

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Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.