(15 days)
No
The description mentions "control circuitry" and "electromechanical devices" but does not use terms like AI, ML, deep learning, or algorithms that suggest AI/ML functionality. The automatic adjustment of suction based on occlusion is described as a direct response, not necessarily an AI/ML driven decision.
No.
The device acts as a suction source to remove fluids and debris, which is a supportive function during a surgical procedure, rather than directly treating a disease or condition.
No
The device is described as a suction source used during surgical procedures to remove fluids and debris, not to provide diagnostic information about a patient's condition.
No
The device description explicitly states it is an "AC-powered, stand-alone device" and an "electromechanical device" consisting of a "vacuum pump and control circuitry," indicating it includes hardware components beyond just software.
Based on the provided text, the SmartSuction Solo 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 interaction with the patient's body during surgery, not an examination of specimens taken from the body.
- Device Description: The device is described as an "AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room." This describes a surgical tool used for physical removal of material.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical functions associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The SmartSuction Solo device is a surgical suction tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician.
The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction Solo device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.
This device is intended for use by trained personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
Product codes
BTA
Device Description
Powered suction pumps are described in FDA regulation, 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® SmartSuction Solo™ (HSS) is a product line extension from the SmartSuction HARMONY™ device, which was cleared by FDA under K052626 in October 2005. The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician. The attending physician is responsible for the proper use of these devices. Therefore, both these devices are to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
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
"trained personnel under the direction of the physician" in the "operating room"
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 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
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
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: | Haemonetics® SmartSuction Solo™ |
|---|---|
| Common Name: | AC Powered Suction Device |
| Classification Name: | AC Powered Suction Pump |
Predicate Device
The predicate device is the SmartSuction HARMONY™ device, cleared under K052626 in October 2005.
Description
Powered suction pumps are described in FDA regulation, 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".
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Image /page/0/Figure/17 description: The image contains the number 4 at the top, followed by the word "HAEMONETICS" in bold, uppercase letters. Below that, the phrase "COMPANY CONFIDENTIAL" is written in a smaller, non-bold font. A horizontal line is above the word "HAEMONETICS".
1
Haemonetics® SmartSuction Solo™ (HSS) is a product line extension from the SmartSuction HARMONY™ device, which was cleared by FDA under K052626 in October 2005. The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician. The attending physician is responsible for the proper use of these devices. Therefore, both these devices are to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
Indications for Use:
The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures.
The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use the SmartSuction Solo device as a suction source for a procedure where 150 mmHg of suction could damage underlying tissue.
Both devices are intended for use by trained operating room personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, both these devices are to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
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 test protocols and reports.
Substantial Equivalence
The substantial equivalence of the SmartSuction Solo is supported by its similarities in intended use, technological characteristics, and performance as compared to the currently marketed SmartSuction HARMONY device. Both devices have technological characteristics. They are similar in design and materials of construction. Both electromechanical devices are the same and consist of a vacuum pump and control circuitry. Verification and validation testing has been completed on the SmartSuction Solo and provide valid scientific evidence to demonstrate the devices are functionally equivalent.
| Date: | August 17, 2006 |
|---|---|
| ------- | ----------------- |
Gabriel J. Muraca, Jr. Regulatory Affairs Project Manager Haemonetics Corporation
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5
HAEMONETICS
COMPANY CONFIDENTIAL
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Image /page/2/Picture/2 description: The image shows a stylized black and white drawing of a bird in flight. The bird's body is represented by three parallel lines that curve and taper towards the tail. The head of the bird is small and pointed, and the wings are suggested by the curved lines that extend from the body. The overall design is simple and abstract, conveying a sense of movement and freedom.
()(') = 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Haemonetics Corporation % Mr. Tamas Borsai TUV Rheinland of North America. Inc 12 Commerce Road Newton. Connecticut 06470
Re: K062801
Trade/Device Name: Haemonetics® SmartSuction Solo™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction cup Regulatory Class: Class II Product Code: BTA Dated: September 18, 2006 Received: September 19, 2006
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) ve regions the Medical Device Amendments, or to commerce prof to May 20, 1778, accordance with the provisions of the Federal Food, Drug, de needs may been rever 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 r ou may, dierelove, mains 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 If your de rise to such additional controls. Existing major regulations affecting your device can may be subject to back as a saterial 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 I Teaso be deviced that I Draination that your device complies with other requirements of the Act that I Drimas intates and regulations administered by other Federal agencies. You must or my 1 oderal statuates and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Furt 007), mooning (21 CFR Part 820), and if applicable, the electronic forth in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Tamas Borsai
This letter will allow you to begin marketing your device as described in your Section 510(k) i mis letter will and in your to be a finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n Joa 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 other general micronal 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,
Mark N. Melkerson
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): K062801
Device Name:
Haemonetics® SmartSuction Solo™
The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician.
The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction Solo device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.
This device is intended for use by trained personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
| 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
COMPANY CONFIDENTIAL
| 510(k) Number | K062801 |
|---|---|
| --------------- | --------- |
HAEMONETICS