(162 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI or ML.
No.
The device is described as "intended for general suction use" and for "the removal or aspiration of fluids and debris," which is a supportive function rather than directly treating a disease or condition. Additionally, it states the pump is "non-patient contacting."
No
The device is described as a general suction pump for the removal or aspiration of fluids and debris, not for analyzing or interpreting information to diagnose a medical condition.
No
The device description clearly outlines hardware components such as a battery-operated pump assembly, DC motor, diaphragm pump, waste collection bag, and physical accessories like tubing and a flow control switch. The performance studies also include tests related to the physical characteristics and functionality of these hardware components (e.g., Leak and Vacuum Test, Max Vacuum Test, Tensile Strength Test, Electrical Safety and EMC Testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general suction use in hospitals or clinics." This describes a physical action (suctioning fluids and debris) and not a diagnostic test performed on samples taken from the human body.
- Device Description: The description focuses on the mechanical function of the pump (providing vacuum pressure, collecting fluids) and its components (motor, diaphragm pump, waste bag, tubing, flow switch). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment. This device does not perform any such analysis.
The device is a medical device used for aspiration and suction, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Quiver Aspiration Pump is intended for general suction use in hospitals or clinics.
Product codes (comma separated list FDA assigned to the subject device)
BTA, JCX
Device Description
The Quiver Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Quiver Aspiration Pump provides battery powered suction for the removal or aspiration of fluids and debris. The Pump is a portable, single-use, non-sterile and provides up to -29inHg vacuum pressure. For sterile field use, the pump is provided with sterile accessory tubing and a sterile flow control switch. The accessories are also single-use and disposable. The Quiver Aspiration Pump system is comprised of the following:
- Quiver Aspiration Pump: The Quiver Aspiration Pump is battery-operated (18VDC, nonrechargeable), has an ON/OFF button, and serves as a vacuum source for aspirating and suctioning for general use applications. Within the pump assembly, the DC motor drives a diaphragm pump that provides high vacuum suction and flows in one direction for material removal only. Affixed to the pump is a waste collection bag (500mL) that collects and contains all fluids and materials that were aspirated. The aspiration pump is non-patient contacting. Sterile aspiration tubing accessories are provided with the pump to facilitate connection to other suction devices with a standard medical luer connection. The inline flow control switch allows the user to initiate and terminate the suction from the distal end of the tubing. The entire pump assembly is disposable following standard biohazard handling procedures.
- Accessories: Included in the pump package are the aspiration tubing and the inline control flow switch. Both accessories are individually packaged in sterile pouches. These components are finished sterile devices manufactured and sterilized by Merit Medical (South Jordan, UT) and sold to Anoxia as finished medical devices. The aspiration tubing has a standard female luer fitting. The inline flow control switch is connected to the distal end of the tubing. The tubing is 72 inches long to allow for use within a sterile field if necessary for general suction applications. The flow switch has a standard male luer that can be connected to other devices used for suction that have the same standard medical luer. The two accessories and the pump are packaged in a carton box.
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
hospitals or clinics
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)
To demonstrate the substantial equivalence of the Ouiver Aspiration Pump to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following tests:
- Visual Inspection Test
- Leak and Vacuum Test (Air)
- Max Vacuum Test (Water)
- Simulated Use Test
- Tensile Strength Test
- System Comparative Test
- Packaging and Shelf-Life Test
- Electrical Safety and EMC Testing
Comparative tests included Peak maximum vacuum pressure (inHg). Maximum vacuum values were obtained after stabilization of the pump was recorded. Comparative testing yielded substantially similar results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2024
Anoxia Medical Inc. % Bosmat Friedman-Cox Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K232831
Trade/Device Name: Quiver Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA, JCX Dated: September 13, 2023 Received: September 13, 2023
Dear Bosmat Friedman-Cox:
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 (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.
1
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; 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.22 08:17:47 -05'00'
Mark Trumbore, Ph.D., GWCPM Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Quiver Aspiration Pump
Indications for Use (Describe)
The Quiver Aspiration Pump is intended for general suction use in hospitals or clinics.
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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4
Quiver Aspiration Pump Traditional 510(k)
Image /page/4/Picture/1 description: The image shows the logo for Anoxia Medical, Inc. The logo features a stylized sun graphic in red and white, followed by the company name in bold, black letters. The text is all capitalized and clearly legible.
510(k) Summary
510(k) Summary [Traditional 510(k)] Quiver Aspiration Pump 510(k) Number K
SUBMITTER 1.
Applicant's Name:
Anoxia Medical, Inc. 3475 Investment Blvd, #9 Hayward, CA 94545
Primary Contact:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com
Date Prepared: September 5, 2023
- DEVICE Trade Name: Quiver Aspiration Pump Device: Pump, Portable, Aspiration (Manual Or Powered) Classification Code: Product Code: BTA Regulation No: 878.4780 Class: 2 Review Panel: General & Plastic Surgery
PREDICATE DEVICE 3.
Penumbra Pump MAX, by Penumbra Inc., Product code JCX, cleared Under: K122756.
DEVICE DESCRIPTION 4.
The Quiver Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Quiver Aspiration Pump provides battery powered suction for the removal or aspiration of fluids and debris. The Pump is a portable, single-use, non-sterile and provides up to -29inHg vacuum pressure. For sterile field use, the pump is provided with sterile accessory tubing and a sterile flow control switch. The accessories are also single-use and disposable. The Quiver Aspiration Pump system is comprised of the following:
- Quiver Aspiration Pump: The Quiver Aspiration Pump is battery-operated (18VDC, nonrechargeable), has an ON/OFF button, and serves as a vacuum source for aspirating and suctioning for general use applications. Within the pump assembly, the DC motor drives a
5
| Quiver Aspiration Pump | |
|---|---|
| Traditional 510(k) 510(k) Summary |
diaphragm pump that provides high vacuum suction and flows in one direction for material removal only. Affixed to the pump is a waste collection bag (500mL) that collects and contains all fluids and materials that were aspirated. The aspiration pump is non-patient contacting. Sterile aspiration tubing accessories are provided with the pump to facilitate connection to other suction devices with a standard medical luer connection. The inline flow control switch allows the user to initiate and terminate the suction from the distal end of the tubing. The entire pump assembly is disposable following standard biohazard handling procedures.
- Accessories: Included in the pump package are the aspiration tubing and the inline control ● flow switch. Both accessories are individually packaged in sterile pouches. These components are finished sterile devices manufactured and sterilized by Merit Medical (South Jordan, UT) and sold to Anoxia as finished medical devices. The aspiration tubing has a standard female luer fitting. The inline flow control switch is connected to the distal end of the tubing. The tubing is 72 inches long to allow for use within a sterile field if necessary for general suction applications. The flow switch has a standard male luer that can be connected to other devices used for suction that have the same standard medical luer. The two accessories and the pump are packaged in a carton box.
5. INDICATIONS FOR USE
The Quiver Aspiration Pump is intended for general suction use in hospitals or clinics.
SUBSTANTIAL EQUIVALENCE 6.
The Quiver Aspiration Pump is substantially equivalent to the predicate device based on the following:
Intended Use
The intended use of the proposed device is identical to that of the cleared device.
Technology
Both the Quiver Pump and Penumbra Pump perform aspiration through a single lumen aspiration tube attached to a continuous aspiration pump with a waste collection element. Any differences between the subject and predicate device were evaluated through comparative performance evaluation and design verification and validation testing which demonstrated device performance and safety. Comparative tests included Peak maximum vacuum pressure (inHg). Maximum vacuum values were obtained after stabilization of the pump was recorded. Comparative testing yielded substantially similar results.
Discussion
Based on the comparison presented in our submission, the Quiver Aspiration Pump shares the same indications for use as the Penumbra Pump MAX, as both are intended for general suction use in hospitals or clinics.
Additionally, The Quiver Aspiration Pump and Penumbra Pump MAX also share the same operating principal and have similar technological characteristics and mechanisms of action as
6
Quiver Aspiration Pump Traditional 510(k)
both serve as the source of vacuum for aspiration of materials. Both systems are provided with sterile aspiration tubing and inline flow control switch. Performance testing was completed to demonstrate safety and effectiveness of the subject device, supporting the company's substantial equivalency claim.
PERFORMANCE DATA 7.
ANOXIA MEDICAL. INC.
To demonstrate the substantial equivalence of the Ouiver Aspiration Pump to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following tests:
- Visual Inspection Test
- Leak and Vacuum Test (Air) ●
- Max Vacuum Test (Water) ●
- Simulated Use Test ●
- Tensile Strength Test
- System Comparative Test
- Packaging and Shelf-Life Test
- . Electrical Safety and EMC Testing
CONCLUSION 8.
The Ouiver Aspiration Pump has the same/similar intended use, technological characteristics, and principles of operation as the predicate. Any differences between the subject and predicate devices were evaluated through design verification and validation testing and comparative testing which demonstrated device performance and safety, and do not raise any new questions of safety and effectiveness.
Based on the information submitted in this 510(k), the Quiver Aspiration Pump is substantially equivalent to the currently marketed predicate Penumbra Pump Max System.