(41 days)
Venous photoplethysmography and bi-directional Doppler for venous and arterial vonous protoproxity and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.
Not Found
This 510(k) submission describes the expansion of indications for use for the Rheo Dopplex® II device to include "screening for the absence of deep venous thrombosis (DVT) in the lower limb." The provided documents contain a summary of the clinical study conducted to support this new indication.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific acceptance criteria for sensitivity, specificity, and predictive values. However, it reports the device performance in these metrics. Without explicitly stated acceptance criteria, it's impossible to determine if the reported device performance met predefined targets. The reported values are presented as descriptive statistics from the study.
| Metric | Reported Device Performance (Rheo Dopplex® II) | Acceptance Criteria (Not explicitly stated in the provided text) |
|---|---|---|
| Sensitivity | 100% | (Not provided in the document) |
| Specificity | 46% | (Not provided in the document) |
| Negative Predictive Value (NPV) | 100% | (Not provided in the document) |
| Positive Predictive Value (PPV) | 51% | (Not provided in the document) |
Note: The low specificity and positive predictive value (PPV) might be a concern in some contexts, but without explicit acceptance criteria, it's difficult to comment on whether these values were considered acceptable by the regulatory body for the intended use of screening for the absence of DVT. High sensitivity and NPV are often prioritized for screening devices where missing a condition could have severe consequences.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set in the clinical studies.
The data provenance is also not explicitly stated (e.g., country of origin). The studies are described as "Clinical data to support this expanded Indications for Use," implying they were conducted to gather evidence for this specific submission. It is not mentioned whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that the clinical data included "studies comparing the Rheo Dopplex® II with duplex imaging and venography for the confirmation of the absence of a DVT in the lower limb."
- Ground Truth Modalities: Duplex imaging and venography are mentioned as the reference standards for DVT confirmation.
- Number of Experts: The number of experts involved in interpreting the duplex imaging and venography results, or in establishing the ground truth, is not specified.
- Qualifications of Experts: The qualifications of any experts involved are not specified.
4. Adjudication Method for the Test Set
The adjudication method for establishing the ground truth from duplex imaging and venography is not described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The Rheo Dopplex® II is a device for physiological measurement (venous photoplethysmography and bi-directional Doppler), not an AI-powered diagnostic imaging system that aids human readers in image interpretation. Therefore, this type of study would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The performance metrics (Sensitivity, Specificity, NPV, PPV) described are for the standalone performance of the Rheo Dopplex® II device. The clinical data directly compares the device's output to established reference standards (duplex imaging and venography) for DVT confirmation. There is no indication of a human-in-the-loop component in how these performance metrics were derived.
7. Type of Ground Truth Used
The ground truth used was established by referencing duplex imaging and venography. These are established clinical diagnostic methods used for confirming the presence or absence of deep venous thrombosis.
8. Sample Size for the Training Set
The document does not mention a "training set". Given that the Rheo Dopplex® II is a physiological measurement device and not described as an AI/ML-based system, the concept of a separate "training set" and "test set" in the context of machine learning model development is likely not applicable here. The "clinical data" described would typically refer to data used for validation/testing of the device's performance against a reference standard.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" is not referenced for this device. The ground truth for the clinical studies (validation/testing) was established using duplex imaging and venography.
{0}------------------------------------------------
JAN 1 2 1999
510(k) SUMMARY
| K Number: | K964699 K984307 |
|---|---|
| Product: | Rheo Dopplex® II |
| Company: | Huntleigh Healthcare Inc. |
| Address: | 227 Route 33 EastManalapan, NJ 07726 |
| Contact Person: | Audrey WitkoDirector of Corporate Affairs |
| Phone: (800) 223-1218, ext. 127Fax: (732) 446-1938 |
This is a supplemental 510(k) submission for expansion of the previously cleared Indications for Use (venous and arterial assessment) to include "screening for the absence of deep venous thrombosis (DVT) in the lower limb."
Clinical data to support this expanded Indications for Use include studies comparing the Rheo Dopplex® II with duplex imaging and venography for the confirmation of the absence of a DVT in the lower limb, with additional studies to confirm repeatability and reproducibility. The studies indicate that the Rheo Dopplex® II provides the following:
- . Sensitivity = 100%
- . Specificity = 46%
- . Negative Predictive Value = 100%
- . Positive Predictive Value = 51%
The Rheo Dopplex® II user manual has been amended to include the procedure and parameters for the screening of the absence of a Deep Venous Thrombosis (DVT) in the lower limb.
There is no change to the original form, fit, function, manufacture or clinical use of the Rheo Dopplex® II. All device safety data was included in the original premarket clearance.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
JAN 1 2 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Audrey Witko Director of Corporate Affairs Huntleigh Healthcare, Inc. 227 Route 33 East Manalapan, NJ 07726
Re: K984307 Rheo Dopplex II Regulatory Class: II/21 CFR 892.1550/21 CFR 870.2780 Product Code: 90 IYN/74 JOM Dated: December 1, 1998 Received: December 2, 1998
Dear Ms. Witko:
We have reviewed your Section 510(k) 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 Rheo Dopplex II, as described in your premarket notification:
Transducer Model Number
VP4, VP5, VP8, VP10
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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
{2}------------------------------------------------
Page 2 - Audrey Witko
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David C. Stegerson
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Center for Devices and Radiological Health
Page _ 1 of _1
510(k) Number (if known): #964699- K 984307
Device Name: Rheo Dopplex® II
Indications for Use:
Venous photoplethysmography and bi-directional Doppler for venous and arterial vonous protoproxity and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Javid A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
(Optional Format 3-10-98)
(Posted July 1, 1998)
Back to the Indications for Use Page
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Rheo Dopplex® 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 Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| MusculoskeletalConventional | ||||||||||
| Musculo skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation (OD)
Yamil A. Seyson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De
510(k) Number K984307
E-3
60
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.. --- No. 4305 r. 4/1
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 Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| MusculoskeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Prescription Use (Per 21 CFR 801.109)
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Javid G. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device
F-3
510(k) Number
65
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No. 4305 P. 5/7
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 Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation (ODE
Daniel C. Segers
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi
പ്പ്-3
510(k) Number
60
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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 Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (specify) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (specify) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | P | ||||||||||||
| Laparoscopic | |||||||||||||
| Musculo skeletalConventional | |||||||||||||
| Musculo skeletal Superficial | |||||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NE Concurrence of CDRH, Office of Device Evaluation (ODE
David C. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological I
510(k) Number
F-3
6d
{8}------------------------------------------------
r. 11/1 No. 43U5
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 Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| MusculoskeletalConventional | ||||||||||
| Musculoskeletal Superficial |
Other (specify) Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PR Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David G. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dey
510(k) Number
E-3
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.