(139 days)
Not Found
No
The summary describes a sterile drape and its physical properties, with no mention of AI or ML.
No
The device is described as a sterile barrier for surgical procedures conducted under MRI imaging, intended to cover instrumentation. It does not exert any therapeutic effect on the patient.
No
This device is described as a "Surgical Drape" intended to provide a sterile covering for MRI instrumentation during surgical procedures. Its function is to create a sterile barrier, and it does not perform any diagnostic functions such as detecting, identifying, or characterizing conditions or diseases.
No
The device description explicitly states it is composed of physical materials (urethane film, polyethylene EVA copolymer film, and polypropylene nonwoven material) and includes a suspension system, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MRI Neuro Surgical Drape is a physical barrier intended to maintain sterility during surgical procedures conducted under MRI imaging. It does not analyze biological samples or provide diagnostic information about a patient's health status.
- Intended Use: The intended use clearly states it's for providing a sterile covering for instrumentation during surgery.
- Device Description: The description focuses on the materials and construction of a sterile barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
This device falls under the category of a surgical accessory or drape, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MRI Procedure drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MR imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
The MRI Procedure Drape is composed of urethane film, polyethylene EVA copolymer film and polypropylene nonwoven material, creating a sterile barrier for a surgical procedure. The construction includes a suspension system that allows the clear film area to move with the patient as they are moved in and out of the MRI scanner bore.
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)
Testing to applicable Standards has been completed with positive outcomes.
Top level of testing performed:
- Sterilization and Shelf Life .
- Performance Testing Bench, including tensile, tear resistance, slow . rate penetration and flammability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
09) 34 3
510(k) (Traditional) Submission Section 5, 510(k) Summary
Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision MRI Neuro Surgical Drape and accessories.
1. Company making the submission:
| Name of Owner: | SurgiVision, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | Ewaddell@surgivision.com |
| Correspondent: | J. Harvey Knauss |
| Address: | 11984 South Evelyn Circle |
| Houston, Texas 77071-3404 | |
| Telephone: | 713-723-4080 |
| Fax: | 713-723-0786 |
| E-mail: | harvey.knauss@gmail.com |
Device Name: 2.
| Common Name: | Surgical Drape and
accessories |
|--------------------|---------------------------------------------|
| Proprietary Name: | MRI Neuro Surgical
Drape and accessories |
| Regulation Number: | 878.4370 |
| Product Code: | KKX |
Predicate Device: 3.
Surgical Concept Designs Surgical Drape, K081476
4. Intended Use Statement:
The MRI Procedure drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MR imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.
1
Description of Device: 5.
The MRI Procedure Drape is composed of urethane film, polyethylene EVA copolymer film and polypropylene nonwoven material, creating a sterile barrier for a surgical procedure. The construction includes a suspension system that allows the clear film area to move with the patient as they are moved in and out of the MRI scanner bore.
-
- Summary of the technological characteristics of the device compared to the predicate device.
| Characteristic | MRI Neuro Drape | |
|---|---|---|
| Classification | 21CFR 878.4370 | 21CFR 878.4370 |
| Regulation | ||
| Product Code | KKX | KKX |
| Prescription | ||
| Device | Yes | Yes |
| Composition | PE and PP | PE |
| Sold Sterile | Yes | Yes |
| Sold Single Use | Yes | Yes |
| MRI Safe | Yes | Unknown |
7. Testing:
Testing to applicable Standards has been completed with positive outcomes.
Top level of testing performed:
- Sterilization and Shelf Life .
- Performance Testing Bench, including tensile, tear resistance, slow . rate penetration and flammability
8. Rx or OTC:
The MRI Procedure Drape is an Rx prescription device per 21 CFR Subpart D.
9. Conclusions:
The MRI Procedure Drape is equivalent to the predicate device in the scope of practical application, effectiveness at this application, and ensuring the safety of its subject.
2
The MRI procedure drape does not raise any new safety or effectiveness issues.
SurgiVision, Inc.
Edward Waddell
Edward Waddell Director of Quality and Regulatory
Date: 9/2/9
Section 5 510(k) Submission Page #
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
SFP 2 2 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SurgiVision, Incorporated C/O Mr. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071
Re: K091343
Trade/Device Name: MRI Neuro Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 2, 2009 Received: September 3, 2009
Dear Mr. Knauss:
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.
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.
4
Page 2- Mr. Knauss
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/ucm1115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony V. Martin
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number: K091343
Device Name: MRI Neuro Drape
Indications for Use: The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.
/Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula M. Murphy, R.Q.
Olylgion Sian=Off) Division of Anesthestology, General Hospital Riadlion Control. Dental Devices
510(k) Number: K091343
Page 1 of 1
Section 4 510(k) Submission Page #
Indcations for use form.doc Delphi Consulting Group Houston, TX 77071