(26 days)
Not Found
No.
The device description clearly states it is an "electrically powered medical suction device" that operates using a "piston pump" to create negative pressure. There is no mention of AI, machine learning, or similar technologies in the device description, intended use, or performance studies. The software analysis refers to a "CLASS B" software classification, which typically relates to basic control and functional software in medical devices, not AI models.
Yes
The device is described as clearing the upper airway by removing fluids, which is a direct intervention to treat a medical condition (fluid accumulation in the airway).
No
The device, Cary, is described as a medical suction device used to remove fluids from the upper airway. Its function is to clear obstructions, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a "handheld, electrically powered medical suction device" with a "reusable drive unit and disposable collection container (pumpister) and tubing." The design of the device involves a piston pump for creating negative pressure. This indicates the device is a physical hardware product, not solely software. While it mentions "Software verification and validation were conducted," this refers to software embedded within a physical device, not a standalone software-only medical device.
No.
Explanation: The device is used for the physical removal of fluids from the airway, not for in vitro examination of specimens derived from the human body.
No.
The document explicitly states "Predetermined Change Control Plan (PCCP) - All Relevant Information: Not Found," indicating that this device does not have an authorized PCCP.
Intended Use / Indications for Use
Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
Product codes
JCX
Device Description
[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper airway
Indicated Patient Age Range
adult patients
Intended User / Care Setting
a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use)
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)
The following non-clinical testing are provided in support of the substantial equivalence determination:
- Operating position: Ability of Cary to operate in any spatial orientation was tested and confirmed.
- Protection devices: Overfill protection and protection against reverse flow were tested to ensure the compliance of Cary protection devices. The results of the testing were within the acceptance criteria.
- Noise: The maximum A-weighted sound pressure level was tested for Cary. The result was within the acceptance criteria apart from 0,5dB excess when the suction tip was blocked. This is considered as an acceptable deviation from the standard requirement as it does not decrease the safety or effectiveness of the subject device when compared to the predicate device.
- Air leakage: Leakage into the collection container assembly was verified for Cary as per standard requirement for general use suction equipment. The results of the testing were within the acceptance criteria.
- Vacuum levels and free air flows: Vacuum levels and free air flows for categories High vacuum/high flow and Low vacuum/low flow were tested for Cary. The results of the testing were within the acceptance criteria.
- Pharyngeal suction equipment: Ability of Cary to evacuate ≥ 200 ml of simulated vomitus in not more than 10 s was tested. The result of the test was within the acceptance criteria.
- Reprocessing Validation: An assessment was conducted for the appropriateness of the manual reprocessing process and for the ability of the intended user to carry out the reprocessing of Cary drive unit per provided instructions (human factors validation testing including reprocessing instructions). The outcome of the validation was within the acceptance criteria.
- Sterilization and Shelf-Life: Cary is not provided as sterile. Shelf-life is applicable only to a filter in Cary pumpister. The filter is not sterile but its shelf-life, determined by the supplier, defines the expiration date of the pumpister which is included the pumpister label. Shelf-life testing is not required for usage of the filter in Cary pumpister.
- Biocompatibility: Biocompatibility of direct-contact material in Cary was confirmed by assessing the cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing in accordance with ISO 10993-1,-5,-10,-11,-18,-23: Biological Evaluation of Medical Devices.
- Software: Software verification and validation were conducted, and documentation provided as recommended by FDA's Guidance "Content of Premarket Submissions for Device Software Functions -Guidance for Industry and Food and Drug Administration Staff". Cary software is classified as CLASS B under the Software Safety Classification per IEC 62304:2006+AMD1:2015 Medical device software - Software life cycle processes, and the software documentation level is "Basic Documentation Level" based on the Guidance "Content of Premarket Submissions for Device Software Functions -Guidance for Industry and Food and Drug Administration Staff".
- EMC and Electrical Safety: The electromagnetic compatibility (EMC) and electrical safety (ES) of Cary were confirmed by the following standards: IEC 60601-1-2:2014+AMD1:2020; IEC 60601-1:2005+AMD1:2012+AMD2:2020; ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
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.
FDA 510(k) Clearance Letter - K251111
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 7, 2025
Excitus AS
℅ Dave Yungvirt
CEO
Third Party Review Group, LLC
25 Independence Blvd
Warren, New Jersey 07059
Re: K251111
Trade/Device Name: Cary
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump
Regulatory Class: Class II
Product Code: JCX
Dated: April 10, 2025
Received: April 11, 2025
Dear Dave Yungvirt:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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K251111 - Dave Yungvirt Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K251111 - Dave Yungvirt Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James H. Jang -S [Digitally signed by James H. Jang -S Date: 2025.05.07 13:27:17 -04'00']
For
Long Chen, Ph.D.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251111
Device Name
Cary
Indications for Use (Describe)
Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary K251111
7 May 2025
Submitter
Applicant Name: Excitus AS
Applicant Address: Hillevågsveien 101, 4106 Stavanger, Norway
Applicant Phone: +47 971 57 784
Applicant contact: Øystein Refseth, CEO, or@excitus.no
Correspondent Name: Innokas Medical Oy
Correspondent Address: Metsänneidonkuja 8 Espoo 02130 Finland
Correspondent Phone: +358 40 5856625
Correspondent Contact: Minna Eskola, QA/RA Specialist, minna.eskola@innokasmedical.fi
Device Classification
Trade Name: Cary
Common Name: Powered suction pump
Classification Name: Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation Number: 878.4780
Product Code: JCX
Legally Marketed Predicate Device
Predicate: K120065
Predicate Trade Name: Laerdal Compact Suction Unit 4 (LCSU 4)
Product Code: JCX
Device Description Summary
[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
Page 6
Intended Use / Indications for Use
Indications for use: Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
Device operation: Cary is a non-sterile, portable, handheld, battery-powered medical suction device designed for field and transport use and for evacuation of fluids.
Intended patient population: adult patients
Intended users: a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use)
Indications for Use Comparison
Subject device Cary is indicated for removal of fluids from the upper airway and the predicate device is to be used to remove fluids from the airway or respiratory support system. This is similar between the subject device and predicate device, with the suction tip length of subject device Cary ensuring use in the upper airway.
Subject device Cary creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. This is the same between the subject device and predicate device.
Subject device Cary is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use). This is the same between the subject device and predicate device.
The indications for use of the subject device and predicate device are essentially the same.
The restriction to use subject device Cary in the upper airway does not affect the safety and effectiveness of the subject device when compared to the predicate device as the design of the subject device (suction tip) ensures use as indicated and efficacy of performance (clearance of airway to allow respiration or ventilation).
Comparison of patient population
Subject device Cary and the predicate device are intended to be used for adult patients. This is the same between the subject device and predicate device.
Page 7
Technological Comparison
The technological characteristics of the Excitus Cary are functionally equivalent to the predicate device, the Laerdal Compact Suction Unit 4 (LCSU 4).
| Device & Predicate Device(s): | Subject Device Cary model IM006764 | Predicate Device Laerdal Compact Suction Unit 4 (LCSU 4) K120065 | Significant Difference |
|---|---|---|---|
| General Device Characteristics | |||
| Operation | Continuous | 30 min ON, 30 min OFF (intermittent) | Different |
| Air leakage |