(12 days)
Not Found
No
The description focuses on automatic pressure adjustment based on occlusion, which is a reactive control mechanism, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts.
No
A therapeutic device is one that treats a disease or condition. This device removes fluids and debris during surgery, which is a supportive function during a procedure, not a treatment itself.
No
The device is described as a suction source used to remove fluids and debris during surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states it is an "AC-powered, stand-alone device" and an "AC-powered suction device," indicating it is a hardware device with a power source and physical components for suction.
Based on the provided information, the SmartSuction HARMONY device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove fluids and debris from the surgical field during surgical procedures. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description reinforces its use as a suction source in the operating room for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SmartSuction HARMONY device's function is purely mechanical and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
BTA
Device Description
"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".
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The SmartSuction HARMONY device is designed to be used intra-operatively by trained operating room personnel under the direction of a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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
1
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".
Indications for Use
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.
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
2
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.
3
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
4
Section 4 - Indications for Use Statement
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Haemonetics® SmartSuction HARMONY™
Indications for Use:
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.
| Prescription Use (Part 21 CFR 801 Subpart D) | X and/or |
|---|---|
| ---------------------------------------------- | ---------- |
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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| (Division Sign-Off) | |
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Division of General, Restorative,
and Neurological Devices HAEMONETICS
COMPANY CONFIDENTIAL
| 510(k) Number | K05 262620 |
|---|---|
| --------------- | ------------ |