(49 days)
Gomco Aspiration Pump, Model 405
Not Found
No
The summary describes a simple suction pump with no mention of AI/ML, image processing, or data analysis capabilities.
No
Explanation: The device is intended for general suction use, which is a supportive function and not a direct therapeutic intervention for a specific disease or condition. It assists in medical procedures rather than treating a medical condition itself.
No
The device description states its intended use is for "general suction" and nowhere does it mention diagnosing medical conditions.
No
The device description explicitly mentions "The Aspiration Pump is designed to be powered by the Power supply" and "provides vacuum of up to 558 mmHg," indicating it is a physical hardware device with a power source and mechanical function (providing vacuum).
Based on the provided information, the Penumbra Aspiration Pump 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 device used for physical suction within a clinical setting, not for testing samples taken from the body (which is the core function of an IVD).
- Device Description: The description focuses on providing vacuum for suction, portability, and power supply. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly described as a general-purpose suction pump for clinical use.
N/A
Intended Use / Indications for Use
The Penumbra Aspiration Pump is intended for general suction use in hospitals or clinics.
Product codes
BTA, JCX
Device Description
The Aspiration Pump is designed to provide general suction for use in hospitals or The Aspiration Pump is designed to the Power supply and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 558 mmHg.
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)
Comparison to Preareds made of similar materials and construction to the predicate The Asphation Fump is made of othe same intended use as the predicate device. The Aspiration Pump meets both internal performance requirements and Underwriters Asphation I unip meets over nectrical safety and electromagnetic compatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gomco Aspiration Pump, Model 405
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
AUG 1 6 2005
1 . . . . . .
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in This Sammary with the requirements of 21 CFR 807.92(c)
Submitted by: Penumbra, Inc. 2401 Merced Street, Suite 200 San Leandro, CA 94577
Contact Person: Theresa Brander-Allen VP of Regulatory and Quality Tel: 510-618-3223 Fax: 510-352-1766 tballen@penumbrainc.com
Date summary prepared: 27 June 2005
Trade Name: Aspiration Pump
Common Name: Powered Suction Pump
Classification Name: 21 CFR Part 878.4780, Apparatus, Suction, Ward Use, Portable, AC-Powered
Device Description:
Device Deseriblion.
The Aspiration Pump is designed to provide general suction for use in hospitals or The Aspiration Pump is designed to the Power supply and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 558 mmHg.
Indication for Use: The Aspiration Pump is intended for general suction use in hospitals or clinics.
Predicate Devices: Gomco Aspiration Pump, Model 405
Comparison to Predicate Devices to Support Substantial Equivalence Determination: Comparison to Preareds made of similar materials and construction to the predicate The Asphation Fump is made of othe same intended use as the predicate device. The Aspiration Pump meets both internal performance requirements and Underwriters Asphation I unip meets over nectrical safety and electromagnetic compatibility testing.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized lines representing its wings and body. The logo is black and white.
Public Health Service
AUG 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Theresa Brandner-Allen VP of Regulatory and Quality Penumbra, Inc. 2401 Merced Street, Suite 200 San Leandro, California 94577
Re: K051758
Trade/Device Name: Penumbra Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA, JCX Dated: August 8. 2005 Received: August 10, 2005
Dear Ms. Brandner-Allen:
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, 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 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.
2
Page 2- Ms. Theresa Brandner-Allen
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/dsma/dsmamain.html
Sincerely vours.
Barbara Brelund for
Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "Penumbra" in a bold, sans-serif font. Above the word is a curved line, and below the word are the words "stroke intervention" in a smaller font. The logo is simple and modern.
Indications for Use
| 510(k) Number (if known): | K051758 |
|---|---|
| Device Name: | Penumbra Aspiration Pump |
| Indications for Use: | The Penumbra Aspiration Pump is intended for general |
| suction use in hospitals or clinics. |
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buell for Melkerson
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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|---|---|
| ------ | ---- |
| 510(k) Number | K051758 |
|---|---|
| --------------- | --------- |
Penumbra Aspiration Pump
Page ii of 32
Penumbra Aspiration Pump
Traditional 510(k): June 28, 2005