(43 days)
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Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device's function (cooling irrigation solutions) is purely mechanical/thermodynamic.
No
The device is described as cooling surgical irrigation solutions or creating slush, which are supportive functions in a surgical setting rather than directly treating a medical condition or restoring a bodily function.
No
Explanation: The device is described as cooling surgical irrigation solutions or creating slush, which are therapeutic or supportive functions, not diagnostic.
No
The provided text describes a device designed to cool surgical irrigation solutions and/or create slush, which implies a physical device with cooling mechanisms, not a software-only solution.
Based on the provided information, the ORS-1075LD is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cool surgical irrigation solutions and/or create slush." This describes a device used during a surgical procedure to prepare materials for use on or within the patient's body.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The description of the ORS-1075LD does not involve any of these activities.
Therefore, the ORS-1075LD is a surgical device used for preparing materials for a procedure, not a diagnostic device used for testing specimens.
N/A
Intended Use / Indications for Use
The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.
Product codes
LHC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5950 Powered heating unit.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design of an eagle or bird-like figure, with three curved lines forming the body and wings.
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: K023283
Trade/Device Name: 1075LD Hush-Slush® Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: September 1, 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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Page 1 of 1
510(k) Number:
Device Name: ORS-1075LD Hush-Slush®
Classification Panel: General Hospital 80TBU
Indications for Use: The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devise Evaluation (ODE) Prescription Use Over-the-Counter Use or
Musiam C. Phoret
(Division Sign-Off) Division of General, Restorative and Neurological Devices
§10(k) Number K023283
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