(49 days)
No
The device description and intended use clearly describe a sterile plastic bag (drape) for covering a surgical device. There is no mention of any computational or analytical functions, let alone AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a sterile plastic bag intended to prevent contamination of another device (SabreSource™) when used in surgical environments. It does not directly treat or diagnose a medical condition.
No
The device is described as a sterile plastic bag (drape) intended to prevent contamination of another device (SabreSource™) in surgical environments. It does not perform any diagnostic function.
No
The device description clearly states it is a "sterile plastic bag" and a "drape," indicating it is a physical, hardware-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination of another device (SabreSource™) in a surgical environment. This is a physical barrier function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is described as a sterile plastic bag with an optically clear window. This is a physical covering, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases, monitor health, or determine treatment options. The SabreSource™ Drape does not fit this description.
N/A
Intended Use / Indications for Use
The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.
The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.
Product codes
79 KKX
Device Description
The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient.
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
Operating room or other surgical environments.
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)
K041846, Microtek Medical, Inc. - Large C-Arm Drape Product Number 4982, Contour Fabricators Number CFI-600, MINRAD INC. - DRTSTM Drape
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
UG 2 6 2004
K041846 510(k) SUMMARY MINRAD INC. SabreSource™ Drape
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Contact Person
John McNeirney MINRAD INC. 847 Main Street Buffalo, NY 14203 Phone: (716) 855-1068 Facsimile: (716) 855-1078 Date Prepared December 19, 2003
Name of Device and Name/Address of Sponsor
SabreSource™ Drape
MINRAD INC. 847 Main Street Buffalo, NY 14203
Device Name
| Trade Name: | SabreSource™ Drape |
|---|---|
| Common Names: | Equipment Cover, Equipment Drape |
| Classification Name: | Light Beam Patient Position Indicator Accessory |
| Surgical Drape and Drape Accessories |
Predicate Devices
- Microtek Medical, Inc. - Large C-Arm Drape Product Number 4982 2) Contour Fabricators Number CFI-600, equipment drape 3) MINRAD INC. - DRTSTM Drape
Intended Use
The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.
Technological Characteristics and Substantial Equivalence
The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient. Any dimensional or design differences between the SabreSource™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with three stylized lines representing its wings. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
Mr. John McNeirney Vice President and CTO MINRAD, Inc. 847 Main Street BUFFALO NY 14203
Re: K041846 Trade/Device Name: SabreSource™ Drape Model 301900 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories
Regulatory Class: II Product Code: 79 KKX Dated: July 28, 2004 Received: July 30, 2004
Dear Mr. McNeirney:
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.
1f your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter watification. The FDA finding of substantial equivalence of your device to a legally promaticated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you deem office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or other world to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SabreSource™ Drape Indications for Use Statement
K041846
510(k) Number (if known):
This is an initial submission; no 510(k) number has been issued.
Device Name:
SabreSource™ Drape
Indications for Use:
The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ (Per 21 C.F.R. 801.109)
(Division Sign-Off
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)