The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries: The product includes sterilizable detachable ultrasound transducer probe and user replaceable batteries. The user interface includes an on/off button, volume control, single 2-1/4" speaker and battery. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic.

AI/ML Overview

The provided text is a 510(k) summary for the Summit Doppler Systems, Inc. STN Probe. It describes the device, its intended use, and claims substantial equivalence to a previously cleared predicate device (LifeDop Doppler Ultrasound System -- w/ 8.0 MHz CW PV Probe K024197).

Crucially, the document states "None provided" for Clinical Testing. This means no acceptance criteria or study data demonstrating the device meets such criteria are present in this submission. The basis for clearance is solely substantial equivalence to a predicate device, assuming similar features, materials, and intended use.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is explicitly stated as not provided in the submitted material.

Summary

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SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. STN Probe

K101816

Name and Address: Summit Doppler Systems, Inc. 4680 Table Mountain Dr. #150 Golden, CO 80403 Phone: (303) 423-7572 Fax: (303) 431-5994 AUG 1 9 2010 Ken Jarrell - President Contact: June 25, 2010 Preparation Date: Device Name: STN Probe Peripheral Vascular Doppler Common Name: Class II per: Classification: FR Number Product Code Diagnostic ultrasonic transducer 892.1570 ITX This product will be used to detect blood flow in veins and arteries. Indications for Use: The LifeDop is a hand-held, battery powered, audio Doppler device Description: used for blood flow detection in veins and arteries: The product includes sterilizable detachable ultrasound transducer probe and user replaceable batteries. The user interface includes an on/off button, volume control, single 2-1/4" speaker and battery. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic. Summit Doppler Systems Substantial Equivalence: Golden, CO LifeDop Doppler Ultrasound System -- w/ 8.0 MHz CW PV Probe K024197, Cleared 1/3/03 Doppler ultrasound technology is the same as substantially equivalent Technologies Summary: device shown above. There is no change in the intended use of the device. None provided Clinical Testing: Based on comparisons of device features, materials, intended use and Conclusion: performance, the STN Probe is shown to be substantially equivalent to the commercially available and legally marketed device indicated above.

Addendum 3/3

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Image /page/1/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the left side of the circular logo.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ken Jarrell President Summit Doppler Systems, Inc. 4680 Table Mountain Dr. #150 GOLDEN CO 90403

AUG 1 9 2010

Re: K101816

Trade/Device Name: STN Probe Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 26, 2010 Received: July 28, 2010

Dear Mr. Jerrell:

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 STN Probe, as described in your premarket notification:

Transducer Model Number

STN Probe - 8 MHz CW PV, Sterilizable

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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jerrell

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

David J. Hayes

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Attachment C - Indication for Use

Indications for Use

510(k) Number (if known):

Device Name: STN Probe

Indications For Use:

Indications For Use: This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Prescription Use (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)

Signature

Page 1 of 3

(Division Sign Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K Kl01816

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Diagnostic Ultrasound Indications for Use Form

LifeDop Doppler Ultrasound System w/ STN Probe - 8.0 MHz CW PV, Sterilizable

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
Transurethal
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: __LifeDop Doppler Ultrasound System __ cleared on K024197, 01/03/2003

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

510K K101816

Prescription Use (Per 21 CRF 801.109)

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Diagnostic Ultrasound Indications for Use Form

STN Probe -- 8 MHz CW PV, Sterilizable

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: _ 8.0 MHz CW PV Probe - cleared on K024197, 01/03/2003

(Please Do Not WRITE BELOW THIS LINE - Continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K161816

Prescription Use (Per 21 CRF 801.109)

Regulation Number and Section

§ 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.