(169 days)
Not Found
No
The description details a mechanical compressor with an electric motor and piston, with no mention of AI/ML terms or functionalities.
No
The device provides compressed air to a nebulizer, but it is not the therapeutic agent itself. It is a component that enables the delivery of medication, which is the therapeutic part.
No
The device is a compressor intended to provide air to a nebulizer, not to diagnose a medical condition. Its function is to
facilitate medication delivery, not to analyze health data or identify diseases.
No
The device description explicitly details physical components like an electrical motor, compressor, and housing, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to provide compressed air to a hand-held medication nebulizer. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the mechanical components of a compressor, which is consistent with a device used for delivering medication via nebulization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Precision Medical, Inc. Minimate compressor is intended to provide Compressed air to a hand held medication nebulizer. This device is not intended as a life supporting device.
Product codes
BTI
Device Description
The compressor is made up of three basic sections
- l. Electrical motor
-
- Compressor
-
- Housing
A 1/30 hp electrical motor drives the air compressor.
The compressor is a piston type, which is self lubricating, thus providing a oil free, air supply to the nebulizer.
The housing provides protection for the components, reduces noise, and dampens the vibration from the compressor. The housing also protects the end user from the components of the device.
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
Not Found
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
Precision Medical, Inc. Minimate compressor PM5 successfully passed tests in the following areas; Mechanical / Climatic Electrical Device Performance
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
510K Precision Medical PM5
DEC 9 2005
510(k) Summary
Precision Medical, Inc. Portable Liquid Oxygen System
Submitter Information
| Submitter | Precision Medical, Inc.
300 Held Drive
Northampton, Pa.
18067 |
|-------------------|------------------------------------------------------------------------|
| Contact | James Parker
Quality Assurance Manager |
| Tel:
Fax: | (610)-262-6090 Extensions 228
(610)-262-6080 |
| Preparation Date: | June 20, 2005 |
Device Name
| Proprietary Name: | Minimate compressor |
|---|---|
| Common Name: | Portable Nebulizer Compressor |
| Classification Name: | Compressor, Air , Portable/73BT |
| Device classification | Class II |
| Classification Number | 868.6250 |
Predicate Device Equivalence
Precision Medical, Inc. is claiming substantial equivalence to Precision Medical Care Mist compressor/ K923324/A
Device Description
The compressor is made up of three basic sections
- l. Electrical motor
-
- Compressor
-
- Housing
A 1/30 hp electrical motor drives the air compressor.
The compressor is a piston type, which is self lubricating, thus providing a oil free, air supply to the nebulizer.
The housing provides protection for the components, reduces noise, and dampens the vibration from the compressor. The housing also protects the end user from the components of the device.
1
Intended Use
To provide compressed air for a hand held medication small volume nebulizer. Not for continuous use. Use must be limited to maximum 30 minute intervals.
Comparison of Technological Characteristics
Precision Medical Inc is claiming equivalence to the Precision Medical, Inc. Care mist compressor Summary of Performance Testing
The Precision Medical, Inc. Minimate compressor PM5 successfully passed tests in the following areas; Mechanical / Climatic Electrical Device Performance
2
Conclusions
In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Minimate compressor PM5 system is safe and effective. The combined testing and analysis of results provides assurance that the device meets it's specifications and is safe and effective for it's intended use.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle, with the words oriented to follow the circular shape.
DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067
Re: K051691
Trade/Device Name: Precision Medical, Inc. MiniMate Compressor Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Nebulizer Compressor Regulatory Class: II Product Code: BTI Dated: November 3, 2005 Received: November 4, 2005
Dear Mr. Parker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have to row and have determined the device is substantially equivalent (for the relevelocal above and have acteringlosure) to legally marketed predicate devices marketed in multions for ass batter to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antendinent, or to do roos 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 approvisions of the Act. The general controls provisions of the Act include controls provisions or 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 If your device is classinod (200 a0010). Existing major regulations affecting (1 Nr.), it har be casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Parker
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 modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I ederal bake is requirements, including, but not limited to: registration r our mast compry was a many (21 CFR Part 801); good manufacturing practice alla listing (21 OF Fire at 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in the quality sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse even 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), rf you desire specific at no 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 may overn 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,
Gyette y. Michin Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
12/8/2005510KPMCopy of 510kPM5compressor120805.doc
Indications for Use
510 (k) number (if known)
Device Name: Precision Medical, Inc.MiniMate compressor
Indications for use:
The Precision Medical, Inc. Minimate compressor is intended to provide The Precision Medical, "the "Minimate" ". The device is intended to be used Comprossed un 10 a this not intended as a life supporting device.
Prescription Use _X (Part 21 CFR 801 Subpart D) And /Or
Over the counter use (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)
hum Saliom
(Division Sign-Off) (Division Sign-Old)
Division of Anesthesiology, General Hospital. Division Control, Dentai Devices
510(k) Number