(65 days)
Not Found
Not Found
No
The summary describes a sterile, single-use equipment cover for a solution warmer, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
This device is described as an "equipment cover" for a solution warmer, not a device that directly or indirectly treats medical conditions or restores bodily functions.
No
The device is described as an equipment cover for a solution warmer, used during surgeries where warm irrigation solution is required. Its function is to cover equipment, not to diagnose a medical condition.
No
The device description clearly states it is an "equipment cover" and a "single use product supplied sterile," indicating it is a physical, sterile drape, not software.
Based on the provided information, the ORS-1000LD Leak Detection Drape is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ORS-1000LD Leak Detection Drape is described as an "equipment cover" for a "Solution Warmer." Its purpose is to cover a piece of equipment used during surgery.
- Intended Use: The intended use is "during various surgeries where warm irrigation solution is required." This relates to a surgical procedure, not the analysis of a biological specimen.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
LHC
Device Description
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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
1
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 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
2
Page 1 of 1
510(k) Number:
・・・・
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 |
|---|---|
| ---------- | --------- |