(40 days)
Not Found
No
The device description and intended use focus on physical accessories (needle guides and probe covers) for ultrasound systems. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device components are accessories (needle guides and probe covers) intended to facilitate the use of an ultrasound system for guidance during needle placement, rather than providing direct therapy.
No
Explanation: The device is a needle guide and probe cover kit, which are accessories used with an ultrasound system to facilitate needle placement and maintain sterility during surgical procedures. It does not perform diagnostic functions itself but assists in performing procedures guided by an imaging modality.
No
The device description clearly outlines physical components like needle guides, conductive gel, elastic bands, and polyethylene sheaths, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as assisting a medical practitioner in placing a needle in a specific structure using ultrasound guidance. This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device components (needle guides, probe covers, gel, bands, sheath) are all accessories used during an ultrasound-guided procedure. They are not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use in a medical procedure involving a patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
SiteRite Needle Guide Kits and SiteRite Probe Cover Kits are intended to be used with Site~Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Product codes
90 ITX
Device Description
Site~Rite Needle Guide Kits - Single use sterile disposable needle guide kit available in 18 GA., 20 GA. and 21 GA. configurations. Each kit contains; 1 set of needle guides, conductive gel, elastic bands and a polyethylene sheath.
Site~Rite Probe Cover Kit – Single use sterile disposable sheath kit. Each kit contains; conductive gel, elastic bands and a polyethylene sheath.
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
medical practitioner
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 was carried out to address the requirements associated with the required 510(k) information Based on March 12, 2000 Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers. (This guidance is referenced for ultrasound accessories on the FDA website, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm?pan el=RA#TopPage, retrieved June 25, 2004.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
OCT 1 9 2004
K042445
Page 1 of 2
510(k) Summary SiteRite® Needle Guide Kits and SiteRite® Probe Cover Kit
Common/Classification Name: Diagnostic Ultrasound Transducer, 21 CFR 892.1570
Bard Access Systems 5425 West Amelia Earhart Drive, Salt Lake City, UT 84116 (801)595-5534 - (801)595-5425 (Fax)
Contact: Charles Morreale; Prepared: September 3, 2004
LEGALLY MARKETED PREDICATE DEVICES A.
The SiteRite Needle Guide Kits and Probe Cover Kit are substantially equivalent to the SiteRite Needle Guide (K931403) and the Protek Medical Products, Inc. Ultrasound Transducer Drape Kit. (K970889).
B. DEVICE DESCRIPTION
Site~Rite Needle Guide Kits - Single use sterile disposable needle guide kit available in 18 GA., 20 GA. and 21 GA. configurations. Each kit contains; 1 set of needle guides, conductive gel, elastic bands and a polyethylene sheath.
Site~Rite Probe Cover Kit – Single use sterile disposable sheath kit. Each kit contains; conductive gel, elastic bands and a polyethylene sheath.
C. INTENDED USE
SiteRite Needle Guide Kits and SiteRite Probe Cover Kits are intended to be used with Site~Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The SiteRite Needle Guide Kits and SiteRite Probe Cover Kit have identical indications for use as the Site~Rite Needle Guide -K931403 and Ultrasound Transducer Drape Kits, Polyethylene. The characteristics of the components within the predicate device are the same as the predicate device. The primarv modifications are suppliers, manufacturing changes and to incorporate the product into Bard Access Systems design control and sterilization methods.
000023
1
K042445
Page 2 of 2
E. TECHNOLOGICAL CHARACTERISTICS
There are no changes made that affect the technological characteristics of the device.
ட் TESTING
Testing was carried out to address the requirements associated with the required 510(k) information Based on March 12, 2000 Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers. (This guidance is referenced for ultrasound accessories on the FDA website, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm?pan el=RA#TopPage, retrieved June 25, 2004.)
G. CONCLUSIONS
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2004
Bard Access Systems, Inc. % Mr. Robert Mosenkis · President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K042445
Trade/Device Name: Site-Rite Needle Guide Kits and Probe Cover Kit Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: October 1, 2004 Received: October 4, 2004
Dear Mr. Mosenkis:
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 (Premarket Approval), 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) r ms lotter wrification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on " 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 acon of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K042445 |
|---|---|
| --------------------------- | --------- |
SiteRite Needle Guide Kits and SiteRite Probe Cover Kit Device Name:
Indications for Use:
SiteRite Needle Guide Kits and SiteRite Probe Cover Kits are intended to be used with Site~Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
( of /
Division of Reproductive, Abdominal,
and Radiological Devices K042445
510(k) Number