(217 days)
This emergency power source accessory (UPS) is intended for use as a short-term emergency power source for ventilators, for hospital use only.
M1145 (UPS1-1.25K-1G-MP)Uninterruptible Power Supply The (UPS)regenerates new clean, ultra precise AC power to ensure reliable and accurate system operations. It allows for operation during generator checks, extended continued brownouts or complete blackouts.
The provided text describes a 510(k) premarket notification for an Uninterruptible Power Supply (UPS) intended for use with ventilators. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a medical imaging or diagnostic AI device.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this document, as it pertains to a hardware device's safety and effectiveness.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of precise, quantifiable acceptance criteria with corresponding performance metrics in the way one would expect for an AI or diagnostic device. Instead, it relies on meeting established safety and electrical standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with UL544 standards | Met |
| Compliance with UL1778 standards | Met |
| Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (Electrical, Mechanical & Environmental Performance Requirements) | Met |
| Compliance with requirements for Vibration, Shock, Fluid Spill Tests | Met |
| Compliance with requirements for Temperature and Humidity Tests | Met |
| Compliance with requirements for Radiated Energy and Magnetic Field Testing | Met |
| Compliance with IEC 601-1 (for electrical evaluation) | Met |
| No safety hazards identified | None identified |
| No design characteristics violating reviewer guidance | None identified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a UPS unit, and testing involved physical product testing according to standards, not data analysis from a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth as typically understood for diagnostic or AI devices is not relevant here. The "ground truth" for this device's performance is adherence to engineering and safety standards, which would be evaluated by qualified testing laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no test set requiring expert adjudication for a medical diagnosis or AI output. The testing results were either "met" or "did not meet" the predefined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. No MRMC comparative effectiveness study was conducted as this is a hardware device, not an AI or diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a standalone UPS device; there is no algorithm or human-in-the-loop performance evaluation in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is compliance with established engineering, electrical, and safety standards (e.g., UL544, UL1778, IEC 601-1, FDA Reviewer Guidance) as determined by contract testing laboratories.
8. The sample size for the training set
This information is not applicable. There is no training set in the context of AI development for this hardware device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this hardware device.
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NOV 2 3 1998
EXHIBIT #1 Page 1 of 3
510 (K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
KG81422 The assigned 510(k) number is :_______________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Clary Corporation 1960 So. Walker Avenue Monrovia, CA 91016-4847
Contact Person: Mr. David Fulton, Director, OEM Sales Date Summary Prepared:
April 16, 1998
Name of the Device: 2.
M1145 (UPS1-1.25K-1G-MP)UPS
Predicate Device Information: 3 .
Onguard 1000, Catalog No. 04311-000 and 043611-011, Cobe Laboratories, Inc., K#870976
Device Description: 4 .
M1145 (UPS1-1.25K-1G-MP)Uninterruptible Power Supply The (UPS)regenerates new clean, ultra precise AC power to ensure reliable and accurate system operations. It allows for operation during generator checks, extended continued brownouts or complete blackouts.
Intended Use: 5.
・
This emergency power source (UPS) is intended for use as a short-term emergency power source for ventilators.
6. Comparison to Predicate Devices:
The predicate device's intended use is for emergency power for a cardiopulmonary bypass heart/lung machine system whereas the subject device's intended use is for emergency power for Ventilators.
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Most parameters are identical with minor differences in load power factor (.8 lagging vs. .7), and typical back-up time (12 minutes vs. 10 minutes). Output power for the predicate is 1000 VA vs. 1250 VA for the subject device.
. ' :
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Model M1145 (UPS1-1.25K-1G-MP) UPS in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.
We conducted UL544 and UL1778 testing on the M1145 (UPS1-1.25K-1G-MP) UPS.
The following testing was conducted by a contract testing laboratory:
- a. Vibration, Shock, Fluid Spill Tests
- b. Temperature and Humidity Tests
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was the contract testing laboratory's conclusion that the M1145 (UPS1-1.25K-1G-MP) UPS tested met all relevant requirements of the aforementioned test.
In addition, the following testing was conducted by a contract testing laboratory and met all requirements.
- and Conducted Electromagnetic a. Radiated Energy and Magnetic Field Testing on the M1145 (UPS1-1.25K-1G-MP) UPS. Testing was conducted per the DCRND Reviewer's Guideline, November 1993.
- b. An electrical evaluation performed in accordance with the DCRND Reviewer's Guideline, November 1993 and IEC 601-1 was performed on the M1145 (UPS1-1.25K-1G-MP) UPS by a contract testing laboratory.
8. Discussion of Clinical Tests Performed:
Non-applicable
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9. Conclusions:
The Clary M1145(UPS1-1.25K-1G-MP)UPS has similar technological characteristics as the predicate device except intended use for the Clary UPS is for emergency power for ventilators vs. emergency power for a cardiopulmonary bypass heart/lunq machine for the predicate. All non-clinical testing revealed no new questions of safety or effectiveness. Thus, when compared to the predicate device, the Clary device did not incorporate any significant changes in intended use, method of operations, material or design that could affect safety and effectiveness.
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510KSUM.EXM TEMP/0100-9
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Ms. Susan D. Goldstein-Falk Clary Corporation c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, NY 11021
Re: K981412 M1145 (UPS1-1.25K-1G-MP) UPS Regulatory Class: II (two) Product Code: СВК Dated: September 16, 1998 Received: September 18, 1998
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Susan D. Goldstein-Falk
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J.VCallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known):__K981412
Device Name: M1145 (UPS1-1.25K-1G-MP) UPS
Indications For Use:
.
This emergency power source accessory (UPS) is intended for use as a short-term This emergency power source for ventilators, for hospital use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kramer
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).