(15 days)
Not Found
No
The document describes a standard ultrasound imaging system with basic features like image freeze, printing, and saving. There is no mention of AI/ML terms, image processing beyond basic display, or any description of training or test data sets which are typical for AI/ML-based devices.
No
The device is described as an ultrasound imaging system used for diagnostic purposes and guidance for medical procedures, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Site-Rite® 5 Ultrasound System is intended to be used for diagnostic ultrasound imaging of fluid flow analysis of the human body in the following clinical applications."
No
The device description explicitly states it is an "ultrasonic pulsed echo imaging system" and mentions hardware components like a probe, scanner, and screen, indicating it is a hardware device with integrated software.
Based on the provided information, the Site-Rite® 5 Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Site-Rite® 5 Function: The Site-Rite® 5 Ultrasound System is an imaging device that uses ultrasound to visualize structures within the human body in real-time. It is used for guidance during procedures (like needle placement) and for diagnostic imaging of organs and structures.
- No Specimen Examination: The device does not examine specimens taken from the body. It interacts directly with the body to produce images.
Therefore, the Site-Rite® 5 Ultrasound System falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Site~Rite® 5 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Site-Rite® 5 Ultrasound System is a lightweight, low-output, real-time B-mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. It offers high resolution imaging to a depth of 6.0 cm. The Site® 5 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, cmergency rooms, angiography suites, catheterization laboratories, etc. In addition, the Site® 5 Ultrasound System is designed with simple operating controls to facilitate easy operation.
Key features of the Site~Rite® 5 Ultrasound System are:
- . Compact, portable, real-time ultrasound scanner with:
- Intuitive controls allowing for rapid and easy operation ■
- . Choice of battery or line voltage power
- 발 Operating parameters of scanner determined by image depth
- . Image freeze frame
- 트 Image printing and saving
- r Large screen
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging System
Anatomical Site
Vascular structures, various organs and structures of the body, Abdominal, Intraoperative (epiaortic scanning), Small Organ (breast, testes, thyroid, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional
Indicated Patient Age Range
Adult, Neonatal
Intended User / Care Setting
Physicians (radiologist or other clinician), bedside, intensive care units, emergency rooms, angiography suites, catheterization laboratories
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)
Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market. Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market.
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
§ 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
KO52517
Site~Rite® 5 Ultrasound System Traditional 510(k)
SEP 2 9 2005
.
.
Section 5: 510(k) Summary of Safety and Effectiveness (21 CFR 807.92(a))
1
5.2 Device Name
| Device Name: | Site-Rite® 5 Ultrasound System |
|---|---|
| Trade Name: | Site-Rite® 5 Ultrasound System |
| Common/Usual Name: | Ultrasonic Pulsed Echo Imaging System and Accessories |
| Diagnostic Ultrasonic Transducers | |
| Classification Name: | 90-IYO - Ultrasonic Pulsed Echo Imaging System |
| 21 CFR 892.1560 – Class II | |
| Diagnostic Device | |
| 90-ITX - Diagnostic Ultrasonic Transducer | |
| 21 CFR 892.1570 - Class II | |
| Diagnostic Device | |
| Classification Panel: | Radiology Devices Panel |
ડ 3 Address and Registration
The addresses and registration numbers of the manufacturer for the Site® 5 Ultrasound System are:
Manufacturer:
5.4
| Submitter Name: | Bard Access Systems, Inc. (BAS)
[Wholly owned Subsidiary of C. R. Bard, Inc.] |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 5425 West Amelia Earhart Drive
Salt Lake City, Utah 84116 |
| Telephone Number: | (801) 595-0700 ext. 5421 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Kimberly Geisler |
| Date of Preparation: | August 9, 2005 |
| Registration Number: | 1720496 |
| Additional Registration Numbers: | C. R. Bard
2212754 |
| Manufacturing Site: | |
| Name: | Dymax Corporation.
[Wholly owned Subsidiary of C.R. Bard, Inc.] |
| Address: | 271 Kappa Drive
Pittsburgh, Pennsylvania 15238 |
| Registration Number: | 2523003 |
| Device Classification | |
| Classification Name: | 90-IYO - Ultrasonic Pulsed Echo Imaging System
21 CFR 892.1560 -- Class II
Diagnostic Device
90-ITX - Diagnostic Ultrasonic Transducer
21 CFR 892.1570 - Class II
Diagnostic Device |
2
રે રે Predicate Device Information
The predicate devices are:
| Device Name: | Site~Rite® IV Ultrasound System |
|---|---|
| Trade Name: | Site~Rite® IV Ultrasound System |
| Common/Usual Name: | Ultrasonic Pulsed Echo Imaging System and Accessories |
| Diagnostic Ultrasonic Transducers | |
| Classification Name: | 90-IYO -- Ultrasonic Pulsed Echo Imaging System |
| 21 CFR 892.1560 - Class II | |
| Diagnostic Device |
90-ITX - Diagnostic Ultrasonic Transducer
21 CFR 892.1570 - Class II
Diagnostic Device |
| Classification Panel: | Radiology Devices Panel |
| Premarket Notification: | K032135, concurrence date July 21, 2003 |
5.6 Device Description
The Site-Rite® 5 Ultrasound System is a lightweight, low-output, real-time B-mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. It offers high resolution imaging to a depth of 6.0 cm. The Site® 5 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, cmergency rooms, angiography suites, catheterization laboratories, etc. In addition, the Site® 5 Ultrasound System is designed with simple operating controls to facilitate easy operation.
Key features of the Site~Rite® 5 Ultrasound System are:
- . Compact, portable, real-time ultrasound scanner with:
- Intuitive controls allowing for rapid and easy operation ■
- . Choice of battery or line voltage power
- 발 Operating parameters of scanner determined by image depth
- . Image freeze frame
- 트 Image printing and saving
- r Large screen
5.7 Intended Use
The Site~Rite® 5 Ultrasound System with associated probes and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or perculaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
The Site~Rite® 5 Ultrasound System is intended to be used for diagnostic ultrasound imaging of fluid flow analysis of the human body in the following clinical applications.
- י Abdominal
- Intraoperative (epiaortic scanning)
- " Small Organ (breast, testes, thyroid, etc.)
- Neonatal Cephalic
3
- 포 Adult Cephalic
- 트 Cardiac
- 트 Peripheral Vascular
- 트 Musculo-skeletal Conventional
The Site~Rite® 5 Ultrasound System is not intended for opthalmic applications.
- 5.8 Substantial Equivalence Summary
New device is compared to marketed device?
Yes.
Does the new device have the same indication statement?
No. The indications for use are the same as the predicate Site~Rite® IV Ultrasound System, except that the indication for intraoperative neurological imaging has been removed. In addition, the Indications for Use statement has been reorganized to emphasize the indication for vascular access guidance:
The Site~Rite® 5 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (in deciding, impact on safety and effectiveness may be considered)?
No. The differences do not alter the intended use of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc?
Not in all regards. The Site® 5 Ultrasound System has an updated design compared to the predicate device. However, both the subject and predicate devices transmit and receive an ultrasound signal that is used to create an image to assist the radiologist or other clinician in placing a needle in the desired location.
Could the new characteristics affect safety or effectiveness?
Yes. The updated design could affect the safety or effectiveness of the technological characteristics are similar to the predicate devices except that the electronics design has been updated from the SiteRite® IV Ultrasound System. The SiteRite® 5 Ultrasound System has been designed for manufacturability and improved reliability. The Site-Rite® 5 Ultrasound System was designed to utilize a single linear array probe with a maximum imaging depth of 6.0cm in place of mechanical sector fluid filled probes of the predicate device.
Do the new characteristics raise new types of safety or effectiveness questions?
No. Safety and effectiveness questions are the same for the predicate and subject devices. Refer to the Risk Analysis Document in Attachment 7.
4
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Testing based on the following standards will be completed in order to evaluate the device's performance. Testing will be completed prior to placing the Site~Rite® 5 Ultrasound System on the market.
- . IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirements for Safety
- 피 IEC 60601-1-1:2000, Medical Electrical Equipment -- Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2:2004, Medical Electrical Equipment Part 1-2: General Requirements for 내 Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
-
- IEC 60601-1-4:2000, Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
- . IEC 60601-2-37:2005, Medical Electrical Equipment - Part 2-37: Particular Reguirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- 포 UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety
- NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment
- NEMA UD-3:2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
Are performance data available to assess effects of new characteristics?
Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market. Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market.
Performance data demonstrate equivalence?
Performance data must demonstrate that the SiteRite® 5 Ultrasound System is substantially equivalent to the SiteRite® IV Ultrasound System prior to placement of the Site~Rite® 5 Ultrasound System on the market.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight.
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bard Access Systems, Inc. Division of C.R. Bard, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K052517
Trade Name: Site~Rite 5° Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed ccho imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: September 13, 2005 Received: September 14, 2005
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal the May 28, 1976, the enactment date of the Medical Device Amendments, or to eoninero prof to the ridg " way" and " with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetions of the Act. The general controls provisions of the Act include requirements for annual provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Site~Rite 5° Ultrasound System as described in your premarket notification:
Transducer Model Number
Site~Rite 5
6
Page 2 - Mr. Robert Mosenkis
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de fior is olabilional controls. Existing major regulations affecting your device can be may of babyer to early in the 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 I Tease of action that your device complies with other requirements of the Act or any I Dri has made a deceminations 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 laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997, "Information for Manufacturers Appondin of (encreove) version Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/industry/support/index.html
7
Page 3 – Mr. Robert Mosenkis
If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez at (301) 594-1212.
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
Enclosures
8
1.2 Statement of Indications for Use
510(k) Number (if known):
K052 SI7
Device Name:
·
Site~Rite® 5 Ultrasound System
Indications for Use:
The Site® 5 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed
Prescription Use X (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 IF NEEDED) _ .___
_..... ........
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marney C brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052517
.0005
. . . ...
9
Site~Rite® 5 Ultrasound System
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | P | |||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
Intraoperative (epiaortic scanning)
Small organ (breast, testes, thyroid, etc.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (Concurrence of CDRH, Office of Device Evaluation (ODE))
Prescription Use (Pcr 21 CFR 801.109)
Nancy C. Langdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052517
000511
10
Site~Rite®) 5 Ultrasound Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | ||||||||||
| Intraoperative (specify) | P | ||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | ||||||||||
| Neonatal Cephalic | P | ||||||||||
| Adult Cephalic | P | ||||||||||
| Cardiac | P | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | ||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
Intraoperative (epiaortic scanning) __________________________________________________________________________________________________________________________________________
Small organ (breast, testes, thyroid, etc.) . . ______________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED). __________________________________________________________________________________________________ (Concurrence of CDRH, Office of Device Evaluation (ODE))
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
Jancyc brogdonPrescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052517
000512