(235 days)
Not Found
Not Found
No
The 510(k) summary describes a sterile equipment cover, which is a passive device and does not mention any AI/ML related terms or functionalities.
No
The device is a sterile equipment cover intended to prevent contamination of non-patient contact equipment, not to treat or diagnose a medical condition.
No
The device is an equipment cover intended to prevent contamination, not to diagnose a medical condition.
No
The device is described as a "single use sterile equipment cover," which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "single use sterile equipment cover" used to "cover and prevent contamination of non-patient contact equipment during various procedures." This describes a device used externally to protect equipment, not a device used to examine specimens in vitro (outside of the body) to provide information about a patient's health.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device's function is purely protective and related to maintaining a sterile environment for equipment.
N/A
Intended Use / Indications for Use
"This single use sterile equipment cover is intended for use by professionals in a sterile clinical setting to cover and prevent contamination of non-patient contact equipment during various procedures."
Product codes
KKX
Device Description
Not Found
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
"professionals in a sterile clinical setting"
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
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH" are arranged in a semi-circle around the left side of the eagle. The letters "A.H." are stacked on the top left of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Radscan Medical Equipment. Incorporated C/O Ms.Dawn Tibodeau Responsible Third Party Official TÜV SÜD America. Incorporated ' 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
JAN - 4 2011
Re: K101350
Trade/Device Name: RadScan Equipment Slicker Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: December 17, 2010 Received: December 20, 2010
Dear Ms. Tibodeau:
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.
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Page 2- Ms. Tibodeau
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 CFR Part 807); labeling (21 CFR Part 801); 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
JAN - 4 2011
510(k) Number (if known): K101350
Device Name: RadScan Equipment Slicker®
Indications For Use: This single use sterile equipment cover is intended for use by professionals in a sterile clinical setting to cover and prevent contamination of non-patient contact equipment during various procedures. The following current models are the subject of this filing.
| RadScan Equipment Slicker Models | ||||
|---|---|---|---|---|
| Part No. Suffix | ||||
| -XXV | A - Length In. | |||
| (cm.) | B - Width In. | |||
| (cm.) | C - Min. Band | |||
| Opening In. | ||||
| (cm.) | Label Suffix | |||
| -0XX | ||||
| DP-SSIP-01V | 21 $\frac{3}{4}$ (55.2) | 19 $\frac{3}{4}$ (50.2) | 9 $\frac{1}{2}$ (24.1) | RME-LBL-001 |
| DP-SSIP-02V | 12 (30.5) | 8 (20.3) | 3 $\frac{1}{2}$ (8.9) | RME-LBL-002 |
| DP-SSIP-03V | 28 (71.1) | 12 (30.5) | 5 $\frac{1}{2}$ 14.0) | RME-LBL-003 |
| DP-SSIP-04V | 31 (78.7) | 21 $\frac{3}{4}$ (55.2) | 10 $\frac{1}{2}$ (26.7) | RME-LBL-004 |
Future models will continue the part / label number sequences, and will be identical in materials, constructions, and indications for use, except for dimensions A, B, & C.
Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clauss-Williams
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
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510(k) Number: K101350