The SmartSuction HARMONY device is an AC-powered suction device intended to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures.

The SmartSuction HARMONY device is not intended for endotracheal suction. The SmartSuction HARMONY device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction HARMONY device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.

Device Description

The SmartSuction HARMONY" device is an AC-powered, stand-alone device, designed to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction HARMONY device is designed to be used intra-operatively by trained operating room personnel under the direction of a physician. Therefore, it is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

AI/ML Overview

The provided text describes a 510(k) summary for the Haemonetics SmartSuction HARMONY device. It outlines the device's intended use and performance testing. However, it does not contain detailed information regarding specific acceptance criteria, the methodology of a study proving those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. The primary focus of the document is on establishing substantial equivalence to a predicate device based on similar technological characteristics and intended use, supported by "bench" performance testing.

Here's a summary of the requested information based only on the provided text, acknowledging what is missing:

Acceptance Criteria and Device Performance

The document states that "Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual." However, the specific acceptance criteria and the reported performance values are not detailed in the provided text.

Acceptance Criteria (Not Detailed in Provided Text)	Reported Device Performance (Not Detailed in Provided Text)
Electrical Safety	Verified (details not provided)
Performance Characteristics (as described in Operation Manual)	Verified (details not provided)
Automatic Suction Adjustment Feature	Automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded.

Note: The document asserts that "Verification and validation testing has been completed on the SmartSuction HARMONY and provide valid scientific evidence to demonstrate the devices are functionally equivalent" to the predicate device. This implies the device met its internal performance and safety criteria, but these criteria themselves are not listed.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The testing is referred to as "Performance Testing - Bench." This suggests laboratory or bench-top testing, not clinical data from patients. No country of origin is specified for data. The testing is implicitly prospective, as it's for a new product verification, but this is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. The testing described is "bench" performance testing, implying measurements against technical specifications rather than interpretations requiring expert consensus.
- Qualifications of Experts: Not applicable/Not specified.
Adjudication method for the test set:
- Adjudication Method: Not applicable/Not specified. The nature of "bench" testing typically involves objective measurements rather than subjective assessments requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through "bench" performance testing and comparison of technological characteristics with a predicate device, not on assessing human reader performance with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The SmartSuction HARMONY is an AC-powered suction device, not an AI algorithm. Its performance is inherent to its electromechanical function.
The type of ground truth used:
- Ground Truth: Not explicitly stated as "ground truth." For "bench" performance testing, the ground truth would typically be the established engineering specifications, safety standards, and functional requirements for the device. The device's ability to "automatically adjust suction up to 150 mmHg negative pressure when the suction tip is occluded" is a performance characteristic verified against a defined standard.
The sample size for the training set:
- Sample Size: Not applicable. This is a hardware device, not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary

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KOS2626 0CT 5 - 2005

Section 5 - 510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Submitter

Haemonetics Corporation 400 Wood Road Braintree, MA. 02184-9114

Contact

Gabriel J. Muraca, Jr. RA Project Manager Haemonetics Corporation 355 Wood Rd. Braintree, MA. 02184-9114 T: 781-356-9553 F: 781-356-9974 Email: gmuraca@haemonetics.com

Device Name

Proprietary Name:	SmartSuction HARMONYTM
Common Name:	AC Powered Suction Device
Classification Name:	AC Powered Suction Pump

Predicate Device

The predicate device is the Medela® Basic 30 Fluid Management System. The Medela device was cleared under K021368 on 5/15/02.

Description

Powered suction pumps are described in FDA regulations, 21 CFR 878.4780, as:

"A powered suction pump is an AC-powered device intended to be used to remove infectious materials from wounds or fluids from 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. The FDA classified the device as a class II medical device".

HAEMONETICS

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Indications for Use

Performance Testing - Bench

Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual. A detailed list of testing is provided with complete test protocols and reports.

Substantial Equivalence

The substantial equivalence of the SmartSuction HARMONY is supported by its similarities in intended use, technological characteristics, and performance as compared to the ourrently marketed Medela® Basic 30 Fluid Management System. Both devices have similar technological characteristics. They are similar in design and materials of construction. Both electromechanical devices consist of a vacuum pump and control circuitry. Verification and validation testing has been completed on the SmartSuction HARMONY and provide valid scientific evidence to demonstrate the devices are functionally equivalent.

Gabriel J. Muraca Jr.

Gabriel J. Muraca, Jr. Regulatory Affairs Project Manager Haemonetics Corporation

September 1, 2005

Date:

COMPANY CONFIDENTIAL

HAEMONETICS

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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 consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." is arranged around the perimeter of the circle.

OCT 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Haemonetics Corporation c/o Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road Newton, Connecticut 06470

Re: K052626

Trade/Device Name: Haemonetics® SmartSuction HARMONY™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: September 19, 2005 Received: September 23, 2005

Dear Mr. Borsai:

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. Iisting 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 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.

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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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara Bueno

Mark N Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Haemonetics® SmartSuction HARMONY™

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)	X and/or
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Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

(Division Sign-Off)
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Division of General, Restorative,
and Neurological Devices HAEMONETICS
COMPANY CONFIDENTIAL

510(k) Number	K05 262620
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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.