(53 days)
This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal (N= new indication)
The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions.
The provided text is a 510(k) premarket notification for the Summit Doppler Systems, Inc. EchoHeart Transvaginal Doppler. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study with acceptance criteria and device performance metrics.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, number and qualifications of experts, adjudication method, MRMC study, standalone performance, ground truth types, and how ground truth was established) cannot be fully populated as they are not explicitly present in the provided document.
However, I can extract information related to the device's intended use and the basis for its clearance.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. The "acceptance criteria" here is implicitly assumed to be "substantial equivalence" to predicate devices, meaning it performs as well as or better than the predicate for its intended use without raising new questions of safety or effectiveness.
| Criteria Category | Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device Performance |
|---|---|---|
| Intended Use | Detect fetal heart tones transvaginally as an aid for determining fetal viability. | Designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient (early gestations, obese patients, retroverted uteri). |
| Technology | Utilize Doppler ultrasound technology similar to predicate devices. | Uses Doppler ultrasound technology. |
| Safety & Effectiveness | Substantially equivalent to predicate devices (no new safety/effectiveness concerns). | Concluded to be substantially equivalent based on device features, materials, intended use, and performance to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific clinical test set (i.e., a study involving human subjects or data collected specifically to test the performance of the EchoHeart Transvaginal Doppler against a defined ground truth). The clearance is based on substantial equivalence, which primarily relies on comparing the new device's features and technological principles to existing, legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no specific test set requiring expert ground truth establishment is described in the document for the EchoHeart Transvaginal Doppler.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a transvaginal Doppler probe, not an AI-powered diagnostic system. No MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware probe used by a human practitioner. It is not an algorithm evaluated for standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's functionality and safety is implicitly tied to the established safety and effectiveness of the predicate devices it is compared against. There is no specific, independent ground truth described as being used for a novel study of the EchoHeart probe itself.
8. The Sample Size for the Training Set
Not applicable, as this is a hardware device (Doppler probe) and not an AI/machine learning algorithm that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
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KOBO41D
7 2006 APR
SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. EchoHeart Transvaginal Doppler
Name and Address: Summit Doppler Systems, Inc. 4620 Technology Dr. #100 Golden, CO 80403 Phone: (303) 423-7572 Fax: (303) 431-5994 Contact: Ken Jarrell - President Preparation Date: February 10, 2006 Device Name: EchoHeart Transvaginal Doppler Common Name: Transvaginal Doppler Probe Classification: Class II per: FR Number Product Code Transducer, Ultrasonic, Diagnostic 892.1570 ITX Indications for Use: This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability. Description: The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions. Substantial Equivalence: The EchoHeart Transvaginal Doppler probe is substantially equivalent to the currently marketed Summit Doppler LifeDop system w/ 3.2 MHz fetal probe and Atlantis Diagnostic International Transvaginal Probe. Summit Doppler Systems, Inc. Atlantis Diagnostics International, Inc. Golden, Colorado Bothell, WA 98011 LifeDop Doppler w/ 3MHz Probe HDI 1000 Diagnostic w/ Transvaginal Probe K024197, Cleared 1/3/03 K961073, Cleared 2/19/97 Technologies Summary: Doppler ultrasound technology is the same as substantially equivalent devices shown above. Conclusion: Based on comparisons of device features, materials, intended use and performance, and user instructions, the LifeDop Doppler is shown to be substantially equivalent to the commercially available and legally marketed
device indicated above.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or bird, with three wing-like shapes stacked on top of each other.
Public Health Service
7 2006 APR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ken Jarrell President Summit Doppler Systems, Inc. 4620 Technology Drive, Suite 100 GOLDEN CO 80403
Re: K060410
Trade Name: EchoHeart Transvaginal Doppler Probe Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: HEK and ITX Dated: February 10, 2006 Received: February 16, 2006
Dear Mr. Jarrell:
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 EchoHeart Transyaginal Doppler Probe used with the LifeDop Doppler Ultrasound System, as described in your premarket notification.
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 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
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Page 2 - Mr. Jarrell
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (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
If you have any questions regarding the content of this letter, please contact Ewa Czerska, M.D. at (301) 594-1212.
Sincerely yours,
David G. Ayres
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
Main unit LifeDop system with EchoHeart Transvaginal Doppler probe
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 | P, E | |||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | N | |||||||||
| Transurethal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P, E | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Previously cleared indication is K024197, issued 1/3/03
Additional Comments: ____ The system consists of main unit plus an EchoHeart Transvaginal Probe
Prescription Use (Per 21 CRF 801.109)
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David G. Ingram
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
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Diagnostic Ultrasound Indications for Use Form
EchoHeart Transvaginal Probe
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 | N | |||||||||
| Transurethal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: ___The above is for EchoHeart Transvaginal Doppler probe
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hyon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Device 510(k) Number
Prescription Use (Per 21 CRF 801.109)
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).