(34 days)
Not Found
No
The summary describes a standard Doppler ultrasound device and makes no mention of AI or ML.
No.
The device is used for detection and diagnostic purposes (detecting fetal heartbeats and blood flow, aiding in determining fetal viability and detecting peripheral vascular disease), not for treating or managing a disease or condition.
Yes
The "Intended Use / Indications for Use" section states the device is used "for aiding in determining fetal viability" and "for assisting in the detection of peripheral vascular disease," which are both diagnostic purposes.
No
The device description explicitly states it is a "portable, battery-powered ultrasound device," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The LifeDop 350 Doppler uses ultrasound to detect fetal heartbeats and blood flow directly within the body. It does not analyze specimens taken from the body.
Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics. It is an in vivo diagnostic device.
N/A
Intended Use / Indications for Use
Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.
Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arterics for assisting in the detection of peripheral vascular disease.
Product codes
KNG, HEP, MAA
Device Description
The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, veins and arterics (Peripheral Vascular)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
MAR 3 1 2009
SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. LifeDop 350 Doppler
Name and Address:
Summit Doppler Systems, Inc. 4680 Table Mountain Dr. #150 Golden, CO 80403
Phone: (303) 423-7572 Fax: (303) 431-5994
Ken Jarrell - President
January 16, 2009
LifeDop 350 Doppler
Portable Doppler, Fetal and Vascular
FR Number Class II per: . 884.2660 Monitor, Ultrasonic, Fetal 884.2660 Monitor, Bloodflow, Ultrasonic
Product Code KNG HEP
Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.
Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arterics for assisting in the detection of peripheral vascular disease.
The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.
Summit Doppler Systems Golden, CO LifeDop Doppler Ultrasound System K024197, Cleared 1/3/03
Doppler ultrasound technology is the same as substantially equivalent device shown above.
None provided
Based on comparisons of device features, materials, intended use and performance, the LifeDop 350 Doppler is shown to be substantially equivalent to the commercially available and legally marketed device indicated above.
Contact:
Preparation Date:
Device Name:
Common Name:
Classification:
Indications for Use:
Description:
Substantial Equivalence:
Technologies Summary:
Clinical Testing:
Conclusion:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Summit Doppler Systems, Inc. % Ms. Dawn Tibodeau Program Manager, Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
MAR 3 1 2009
Re: K090499
Trade/Device Name: LifeDop 350 Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: MAA Dated: March 16, 2009 Received: March 18, 2009
Dear Ms. Tibodeau:
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 LifeDop 350 Doppler, as described in your premarket notification:
Transducer Model Number
SD2 -- 2.1 MHz CW Fetal Probe SD3 - 3.2 MHz CW Fetal Probe SD4 - 4.0 MHz CW Peripheral Vascular Probe SD8 - 8.0 MHz CW Peripheral Vascular Probe
2
Page 2 - Ms. Tibodeau
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 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours.
ne M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Indications for Use
510(k) Number:
Device Name:
Indications for Use:
LifeDop 350 Doppler
Obstetrical:
This product will be used to detect fetal heart beats as an aid for determining fetal viability.
Vascular:
This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Prescription Use ਮ (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)
Hula Reum
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Page 1 of 1
Addendum sheet 2 of 6
4
Attachment C - Indication for Use
Diagnostic Ultrasound Indications for Use Form
Main unit fetal system with either 2.1 MHz CW or 3.2 MHz CW Main unit peripheral vascular system with either 4.0 MHz CW 8.0 MHz CW
Man unit perfoneral vasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | ||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: 2.1 MHz CW Fetal Probe - Previously cleared K024197
3.2 MHz CW Fetal Probe - Previously cleared K024197
3.2 MHz CW Fetal Probe - Previously cleared K024197
4.0 MHz CW PV Probe - Previously cleared K024197
8.0 MHz CW PV Probe - Previously cleared K024197
Neil A. Clemm
THE EVSE DO NOT MATE BETOM THIS TIME - CONTIMIE ON WAOTHER EVEE TE REEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
Prescription Use (Per 21 CRF 801.109)
5
SD2 - 2.1 MHz CW Fetal 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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | |||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: __ Previously cleared on K024197, cleared 1/3/03
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEQED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109) Diagnostic Ultrasound Indications for Use Form
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
6
SD3 — 3.2 MHz CW Fetal 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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | |||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: ___Previously cleared on K024197, cleared 1/3/03
510(k) Number
(PLEASEDO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109) Diagnostic Ultrasound Indications for Use Form
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
28
7
SD4 – 4.0 MHz CW Peripheral Vascular 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 | Color Doppler | Amplitude Doppler | Color Velocity Imaging | 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-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Previously cleared on K024197, cleared 1/3/03 Additional Comments: _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109) Diagnostic Ukrasound Indications for Use Form
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090499
8
SD8 – 8.0 MHz CW Peripheral Vascular Probe
SD8 – 8.0 MHz CW Penpheral Vascular 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 | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Smali Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: __ Previously cleared on K024197, cleared 1/3/03THE EASE DO NOT WRITE BELOW THIS LINE - CONTIMUE ON ANDILIERS PAGE IS NEEDED. DONCLURITE DECOM Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109) Diagnostic Ultrasound Indications for Use Form
(Division Sign-Off)
Division of Reproductive, Abdominal and
- Radiological Devices 510(k) Number
ﺍﻟﻘﺪ ﺗﺼﻔﻴﺎﺕ
30