(10 days)
The SiteRite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The SiteRite IV Ultrasound System is not intended for ophthalmic applications.
The Site-Rite IV pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist clinicians in gaining vascular access to major veins, arteries and organs. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical settings: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. The Site-Rite IV ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe. The disposable items, supplied in sterile packs, are currently marketed products.
The provided 510(k) summary for the Site~Rite IV Ultrasound Scanner (K032135) does not contain acceptance criteria or detailed study results directly proving the device meets specific performance acceptance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (SiteRite 3 Ultrasound Scanner K993624 and Dymax SiteRite II Ultrasound System K862127). The core argument is that the Site~Rite IV has identical indications for use and similar technological characteristics, with updates primarily for manufacturability and reliability, and that these differences do not raise new questions of safety and effectiveness.
Here's an breakdown of the information available, and what is explicitly not included based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided within this document.
The document states: "Performance data are presented in the 510(k) and these data demonstrate equivalence." However, the summary itself does not contain a table of specific acceptance criteria (e.g., image resolution targets, penetration depth targets) or quantitative performance metrics for the Site~Rite IV or its predicates. The "performance data" mentioned would be in a separate, more detailed section of the 510(k) submission, not summarized here.
The document does mention the following capabilities:
- Imaging Depth: "high resolution imaging to the depth of 18 cm."
- Depth Range (by probe):
- 9.0 MHz probe: minimum 0.5 cm
- 3.5 MHz probe: maximum 18 cm
These are descriptive capabilities, not acceptance criteria with specific thresholds.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/provided for a specific "test set" demonstrating acceptance criteria.
The submission relies on equivalence to predicate devices and general standards. It mentions: "Clinical studies carried out using the SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite for needle placement in a number of different vascular and non-vascular applications. These studies are summarized and reports are included in the 510(k)."
- Sample Size: Not specified.
- Data Provenance: "Clinical studies carried out using the Site~Rite 2 device" - implying these were conducted prior to this submission and likely involved human subjects for clinical usefulness. The country of origin and whether they were retrospective or prospective are not mentioned in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/provided.
Since there's no specific "test set" for the SiteRite IV's de novo performance assessment, there's no mention of experts establishing ground truth for such a test. The reliance is on the predicate device's established performance and the SiteRite IV's equivalent characteristics.
4. Adjudication Method for the Test Set
Not applicable/provided.
Again, without a specified "test set" for performance evaluation, adjudication methods are not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, there is no mention of an MRMC comparative effectiveness study.
The submission does not discuss human readers, AI, or improvements with AI assistance. This device is an ultrasound scanner, not an AI-powered diagnostic tool in the sense of the examples typically related to MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable/provided.
This device is an imaging system for clinical use with a human operator, not a standalone algorithm.
7. The Type of Ground Truth Used
Not explicitly stated for the Site~Rite IV.
For the predicate Site~Rite 2 device, the "clinical studies" likely established "usefulness" in needle placement based on medical outcomes or expert observation during procedures ("clinical utility"). This would generally fall under outcomes data or expert observation/clinical assessment from the real-world use of the device for its intended purpose.
8. The Sample Size for the Training Set
Not applicable/provided.
This is a traditional medical imaging device, not a machine learning or AI-based system that would typically have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable/provided.
As above, this concept does not apply to the type of device and submission described.
Summary of Device Performance and Equivalence Argument:
The SiteRite IV Ultrasound Scanner demonstrates its "performance" and meets regulatory requirements by demonstrating substantial equivalence to its predicate devices (SiteRite 3 and Site~Rite II).
- Identical Indications for Use: The Site
Rite IV has the same intended uses as the SiteRite 3. - Technological Characteristics: Similar to predicates, with updates for manufacturability and reliability, particularly a digital design (like Site
Rite 3) compared to the analog SiteRite II. - Transducers: Unchanged from currently marketed products. The submission lists 3.5 MHz, 5.0 MHz, 7.5 MHz, and 9.0 MHz probes, each with various B-mode clinical applications (Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Conventional Musculo-skeletal, and Pediatric for some).
- Testing: Electrical safety, electromagnetic emissions, and acoustic output testing were performed, and the results demonstrate equivalence with predicate devices and meet FDA guidance recommendations.
- Clinical Studies (Predicate Device): Usefulness for needle placement was shown with the Site
Rite 2 device, which uses the same transducers and image processing algorithms as the SiteRite IV. This supports the clinical utility and performance of the underlying imaging technology.
In essence, the "study that proves the device meets the acceptance criteria" in this case is the demonstration of substantial equivalence through comparative analysis with predicate devices and adherence to relevant FDA guidance and safety standards, rather than a de-novo study with specific quantitative acceptance criteria for image quality or diagnostic accuracy for the Site~Rite IV itself.
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510(k) Summary Site~Rite IV Ultrasound Scanner
Common/Classification Name: Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560
Dymax Corporation 271 Kappa Drive, Pittsburgh, PA 15238 (412)963-6884 – (412)963-6179 (Fax)
JUL 2 1 2003
Contact: Charles Morreale; Prepared: June 30, 2003
LEGALLY MARKETED PREDICATE DEVICES A.
The SiteRite IV Ultrasound Scanner is substantially equivalent to the SiteRite 3 Ultrasound Scanner (K993624) and the Dymax Site~Rite 11 Ultrasound System (cleared as the Dymax Plus 1 Scanner, K862127).
DEVICE DESCRIPTION B.
The Site-Rite IV pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist clinicians in gaining vascular access to major veins, arteries and organs. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical settings: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc.
The Site-Rite IV ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe.
The disposable items, supplied in sterile packs, are currently marketed products.
C. INTENDED USE
The Site~Rite IV ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound quidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously.
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The Site~Rite IV is not intended for opthalmic applications.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The SiteRite IV Ultrasound Scanner has identical indications for use as the SiteRite 3 Ultrasound System.
The technological characteristics are similar to the predicate devices except that the electronics design has been updated from the SiteRite 3 Ultrasound System. The SiteRite IV Ultrasound System has been designed for manufacturability and improved reliability. The transducers, however, are unchanged from the currently marketed products.
The differences in technological characteristics do not raise new types of questions of safety and effectiveness. There are standard methods for accessing safety and performance, primarily through the methods spelled out in the FDA quidance. Performance data are presented in the 510(k) and these data demonstrate equivalence.
TECHNOLOGICAL CHARACTERISTICS ய்
The primary difference in the SiteRite IV Ultrasound System and the SiteRite II Ultrasound System is that the older SiteRite II has a generator with an analog design, whereas the SiteRite IV Ultrasound System and the Site~Rite 3 Ultrasound Systems are digital in design.
F. TESTING
Testing was carried out to address electrical safety, electromagnetic emissions, and acoustic output. Data from this testing demonstrate equivalence with the predicate devices and meets the recommendations of the FDA document, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.
Clinical studies carried out using the SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite for needle placement in a number of different vascular and non-vascular applications. These studies are summarized and reports are included in the 510(k).
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.
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Image /page/2/Picture/13 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized image of an eagle's head and wing. The eagle's head is facing left, and the wing is represented by three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2003
Dymax Corporation % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH PA 19462-1298
Re: K032135
Trade Name: Site~Rite IV Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: July 10, 2003 Received: July 11, 2003
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 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Site~Rite IV Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 3.5 MHz |
|---|
| 5.0 MHz |
| 7.5 MHz |
| 9.0 MHz |
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If 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 vour 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 vour 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.
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 Seeking Marketing Clearance of Diagnostic 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 (301) 594-4591. 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 by reference to premarket notification" (21 CFR Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
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Page 3 - Mr. Mosenkis
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
David W. Hyam
Nancy C. Brogdon 1 Director. Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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STATEMENT OF INDICATION FOR USE
510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 5
Device Name: Site~Rite IV Ultrasound System___________________________________________________________________________________________________________________________________
Indications For Use:
The Site~Rite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously.
The Site~Rite IV Ultrasound System is not intended for ophthalmic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use -------
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Appendix F
3.5 MHz Probe
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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(Specify) | ||||||
| Clinical Applications | A | B | M | PWD | CWD | |||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | P | |||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Transesophageal | P | |||||||||
| 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 – Epiatoric 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)
い
Prescription Use (Per 21 CFR 801.109)
David A. Lynn
(Division Sign-Off) Division of Reproductive, and Radiological Devices F-3 510(k) Number
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Appendix F
5.0 MHz Probe
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | P | |||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Transesophageal | P | |||||||||
| 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 - Epiatoric 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 (Per 21 CFR 801.109)
and the same of the same of the same of the same of the states of the states and
David A. Lyon
(Division Sign-Off) Division of Reproductive, Abdom ഒ പ്രവേരിogical Devices 51 (x) Number_
F-3
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7.5 MHz Probe
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:
| 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 | P | |||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | ||||||||||
| 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 – Epiatoric 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 (Per 21 CFR 801.109)
Daniel A. Symm
(Division Sign-Off) Division of Reproductive, and Radiological Devi 510(k) Number
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9.0 MHz Probe
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | ||||||||||
| 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 – Epiatoric 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)
David A. Segner
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive. Abdominal, and Redictogical Device 510(k) Number _
and the comments of the comments of the comments of
E-3
くいで
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.