ORS-3000LD

K023282 · O.R. Solutions, Inc. · LHC · Nov 13, 2002 · Physical Medicine

Device Facts

• Record ID: K023282
• Device Name: ORS-3000LD
• Applicant: O.R. Solutions, Inc.
• Product Code: LHC · Physical Medicine
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

Intended Use

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.

Device Story

The ORS-3000LD is a single-use, sterile equipment cover designed specifically for the ORS-1075LD Hush-Slush machine. It functions as a protective barrier during surgical procedures where the machine is used to prepare or maintain slush or cold solutions. The device is intended for use in an operating room environment by surgical staff. By providing a sterile cover, it helps maintain the sterile field while allowing the operation of the slush machine, thereby supporting the clinical need for cold solutions during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, sterile equipment cover. Designed for compatibility with the ORS-1075LD Hush-Slush machine. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a sterile equipment cover for the ORS-1075LD Hush-Slush machine during surgical procedures requiring slush or cold solutions.

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.

Reference Devices

• ORS-1075LD Hush-Slush machine

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: K023282

Trade/Device Name: ORS-3000LD Equipment Cover Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: September 15, 2002 Received: October 1, 2002

Dear Mr. Hannes:

This letter corrects our substantially equivalent letter of November 13, 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 (OS) 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 8091 ), 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 yours,

# 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:

## Device Name: ORS-3000LD

Classification Panel: General Hospital 80WHO

Indications for Use: The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.

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### Concurrence of CDRH, Office of Devise Evaluation (ODE)

or

Prescription Use_

Over-the-Counter Use

Muriam C. Purret

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

510(k) Number Kc:23282

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