M1145 (UPS1-1.25K-1G-MP) UPS

K981412 · Clary Corp. · CBK · Nov 23, 1998 · Anesthesiology

Device Facts

• Record ID: K981412
• Device Name: M1145 (UPS1-1.25K-1G-MP) UPS
• Applicant: Clary Corp.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2

Indications for Use

This emergency power source accessory (UPS) is intended for use as a short-term emergency power source for ventilators, for hospital use only.

Device Story

The M1145 (UPS1-1.25K-1G-MP) is an Uninterruptible Power Supply (UPS) designed to provide short-term emergency power to ventilators during generator checks, brownouts, or blackouts. The device functions by regenerating clean, precise AC power to ensure continuous operation of connected medical equipment. It is intended for hospital use. By maintaining power during electrical interruptions, the device supports the reliable operation of life-sustaining ventilation equipment, thereby preventing potential patient harm due to power loss.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including vibration, shock, fluid spill, temperature, humidity, electromagnetic compatibility, and electrical safety evaluations (UL544, UL1778, IEC 601-1).

Technological Characteristics

Uninterruptible Power Supply (UPS) providing 1250 VA output. Electrical safety and performance tested per UL544, UL1778, and IEC 601-1. Features include 0.8 lagging load power factor and 12-minute typical backup time. Device is designed for hospital environment use.

Indications for Use

Indicated for use as a short-term emergency power source for ventilators in a hospital setting.

Regulatory Classification

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.

Predicate Devices

• Onguard 1000, Catalog No. 04311-000 and 043611-011, Cobe Laboratories, Inc. (K870976)

Submission Summary (Full Text)

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# NOV 2 3 1998

K981412

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.

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### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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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 _