(128 days)
Not Found
No
The summary describes a standard medical air compressor with an automatic backup function, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device provides compressed air to ventilators, which are therapeutic devices, but the compressor itself does not directly provide therapy.
No
The device is an air compressor that provides compressed air to ventilators, it does not diagnose medical conditions.
No
The device description explicitly states it is an "air compressor" and describes its physical function of delivering compressed air, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide compressed air to ventilators. This is a life support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description clearly states it's an air compressor for use in intensive care units or recovery rooms to supply air to ventilators. It's classified as a "Portable Air Compressor" under 21 CFR Part 868.6250, which falls under the category of Anesthesiology Devices. IVDs are typically classified under different parts of the CFR, such as Part 866 (Immunology and Microbiology Devices) or Part 864 (Hematology and Pathology Devices).
- No Mention of Diagnostic Testing: The document does not mention any form of testing on biological samples (blood, urine, tissue, etc.) or the diagnosis of any disease or condition.
- No Mention of IVD-Specific Information: The document lacks information typically found in IVD submissions, such as details about reagents, calibrators, controls, or performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.).
The device is a medical device, specifically a life support accessory, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Independence™ Medical Air Compressor is intended to provide compressed air to ventilators.
The device is intended for use in hospitals and hospital-type facilities.
The device is not to be used in the presence of flammable anesthetics.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel
Product codes (comma separated list FDA assigned to the subject device)
BTI
Device Description
The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1.
The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.
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 and hospital-type facilities.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel
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)
Performance testing was conducted per internal, company requirements while environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93). The Independence™ Compressor device is also compliant with various voluntary and international standards including: IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
In summary eVent Medical Ltd. has demonstrated the Independence™ Medical Air Compressor to be safe and effective.
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
§ 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
Image /page/0/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K040220". The characters are written in a cursive style, with some connections between the letters and numbers.
SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | eVent Medical Ltd. |
|---|---|
| DATE: | January 29, 2004 |
| COMMON NAME: | Medical Air Compressor |
| PROPRIETARY NAME: | Independence™ Medical Air Compressor |
| CONTACT: | Robbie Walsh, VP Quality Assurance & Regulatory Affairs |
| eVent Medical Ltd. | |
| 6A Lisoban Business Park | |
| Tuam Road | |
| Galway, | |
| Ireland. | |
| Tel: + 353 91 764472 | |
| Fax: + 353 91 764379 | |
| CLASSIFICATION: | Class II per 21 CFR 868.6250 |
| Portable Air Compressor. |
PREDICATE DEVICES:
eVent Medical Ltd.. is claiming substantial equivalence to the following predicate medical device:
| Predicate Device | 510(k) Number | Classification |
|---|---|---|
| Drager Inc. Medical Air | ||
| Compressor, Model 98 | K982789 | Class II, |
| Portable Air Compressor | ||
| per 21 CFR 868.6250 |
1
Device Description: A
The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1.
The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.
Intended Use: B
The Independence™ Medical Air Compressor is intended to provide compressed air to ventilators.
The device is intended for use in hospitals and hospital-type facilities.
The device is not to be used in the presence of flammable anesthetics.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel
C Substantial Equivalence:
The intended use of the Independence™ Medical Air Compressor is the same as that for standard, currently marketed medical air compressors. The materials and design of this device are similar to those of the predicate device (Drager Inc. Medical Air Compressor, Model 98, K982789). The technical characteristics of the Independence™ Medical Air Compressor do not introduce new questions regarding safety or effectiveness. Furthermore, the labeling associated with the Independence™ Medical Air Compressor provides similar information as the predicate device.
Information provided in the 510(k) submission supports the determination of substantial equivalence. Performance testing was conducted per internal, company requirements while environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93). The Independence™ Compressor device is also compliant with various
2
voluntary and international standards including: IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
In summary eVent Medical Ltd. has demonstrated the Independence™ Medical Air Compressor to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring three horizontal lines above a wavy line, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
Mr. Robbie Walsh Vice President, Regulatory Affairs & Quality Assurance Event Medical, Ltd. 6A Liosban Business Park, Tuam Road, Galway, Ireland
Re: K040220
Trade/Device Name: Independence Medical Air Compressor Regulation Number: 21 CFR 868.6250 Regulation Name: Compressor, Air, Portable Regulatory Class: II Product Code: BTI Dated: May 14, 2004 Received: May 17, 2004
Dear Mr. Walsh:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviews 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 ass suited in also 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 nave been toot 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 thereore, manier are as a vice include requirements for annual registration, listing of devices, good controller provisions or ulabeling, 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 may of subjoct to cler. adam 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); an the Ace o FFR Part 801); good manufacturing practice requirements as set forth in the quality
4
Page 2 – Mr. Robbie Walsh
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation in
ternation of the country of the Arth 21 CFR 1000-1050 systems (QS) regulation (21 CFR-1 at 626), and S20), 21 CFR 1000-1050.
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 31 t-34 of the Act, 21 cm described in your Section 510(k)
This letter will allow you to begin marketing your device to a legall This letter will allow you to begin marketung your actives of your device of your device of your device to a legally
premarket notification. The FDA finding of substantial e premarket notification. The FDA finding of substantial equil 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
r and the many of the many of the Also, also, also, also, also, also, also If you desire specific advice for your device on our mooning mease note the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note You contact the Office of Compliance at (301) 594-400. 71037 Part 807.97). You may obtain other
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premailities under the Act from the Division of Small
general information on your responsibilities under the est its a pumber (800) 6 general information on your responsibilities uncern and the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800). Manufacturers, International and Collsumer Assistance at is teach .
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
Indications for Use
| 510(k) Number: | K040220 |
|---|---|
| Device Name: | Independence™ Medical Air Compressor |
| Indications for Use: | The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators. |
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Quis Secom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040220
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