ORS-1000LD

K021288 · O.R. Solutions, Inc. · LHC · Jun 27, 2002 · Physical Medicine

Device Facts

• Record ID: K021288
• Device Name: ORS-1000LD
• Applicant: O.R. Solutions, Inc.
• Product Code: LHC · Physical Medicine
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

Intended Use

The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.

Device Story

The ORS-1000LD Leak Detection Drape functions as a sterile, single-use equipment cover for the ORS-2000LD Solution Warmer. Used in surgical settings, it provides a protective barrier for the warming unit while irrigation solutions are prepared for patient use. The device is intended to facilitate the safe application of warm irrigation fluids during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, sterile equipment cover. Designed for use with the ORS-2000LD Solution Warmer.

Indications for Use

Indicated for use as an equipment cover for the ORS-2000LD Solution Warmer during surgical procedures requiring warm irrigation solution.

Regulatory Classification

Identification

A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 0 2017

Mr. Steve Hannes President OR Solutions, Inc. 3901 Centerview Dr., Suite W Chantilly, Virginia 20151

Re: K021288

Trade/Device Name: ORS-1000LD Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: April 3, 2002 Received: April 23, 2002

Dear Mr. Hannes:

This letter corrects our substantially equivalent letter of June 27, 2002.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Steve Hannes

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

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Device Name: ORS-1000LD

Classification Panel: General Hospital 80WHO

Indications for Use: The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.

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Concurrence of CDRH, Office of Devise Evaluation (ODE)

| Prescription Use | ✓ | or | Over-the-Counter |
|------------------|---|----|------------------|
| Use | | | |

(Division Sign-Off)
Division of General, Restorati and Neurological Devices

| K Number | K021288 |
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