The Hemo-Dop® is a medical device to detect blood vessels supplying haemorrhoids and the subsequent HAL for haemornolds of state if and in. It can asso be assul as work opportunities in the used for measuring the Sciero-theraby and Banceries and veins subcutaneous.

Device Description

The Hemo-Dop® consists of two parts. A proctoscope with implemented ultrasound probe and a basic unit which processes and displays the ultrasound signals. The processes of 360° can be insonated. When the ultrasound radiation meets a blood vessel, the frequency shift can be heard and it is graphically displayed. With the bullent of the vessel but also the depth in which it hows. Through the user not only Knows the exact position of the vessel. Since in the area behind the linear the procloscope the user can logate the roose. The can be treated as outpatient of the black defitate the pattent doesn't ficed a general or lobal thabethesia and reliable evaluation of the blood flow signals of the extracranial and peripheral vessels.

AI/ML Overview

Here's an analysis of the provided documents regarding the Hemo-Dop® device's acceptance criteria and study information, structured to address your questions.

Important Note: The provided text is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself. Therefore, many of your requested items (like specific acceptance criteria for a performance study, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not present in this type of document. The 510(k) process relies on demonstrating the device is as safe and effective as a legally marketed predicate, often through comparisons of technical characteristics and existing clinical use of the predicate.

Hemo-Dop® 510(k) Summary Analysis

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary, formal "acceptance criteria" for a specific performance study of the Hemo-Dop® device against a diagnostic benchmark are not explicitly stated in the way you might find in a clinical trial report. Instead, the "performance" discussed primarily relates to acoustic output measurements and substantial equivalence to predicate devices.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (Hemo-Dop®)
Acoustic output within FDA recommended limits	8MHz Pencil Probe PW mode: ISPTA.3: 334 mW/cm² (Max Value), Power: 10.2 mW ISPTA.1: 1.86 mW/cm² (Max Value), Power: 10.2 mW (Stated: "acoustic output is under by the FDA recommended limit and power level is displayed all the time.")
	8MHz Proctoscope Probe PW mode: ISPTA.3: 8.1 mW/cm² (Max Value), Power: 0.74 mW SPPA.3: 0.04 W/cm² (Max Value), Power: 0.74 mW (Stated: "acoustic output is under by the FDA recommended limit and power level is displayed all the time.")
Substantial equivalence to predicate ultrasound Doppler systems	Identified predicate devices: KOVEN TECHNOLOGY INC.; Model KM-25 (K951449) and DWL Elektronische Systeme GmbH; Multi-Dop® L (K930458). (Conclusion states: "the Hemo-Dop is safe and effective and substantially equivalent to predicate devices described herein.")
Conformance to voluntary electrical safety and EMC standards	Conforms to EN60601-1, EN60601-1-1, EN60601-1-2.
Biocompatibility of patient contact materials	All specified materials (PMP, PPSU black, EP42HT, Photobond 4442 for proctoscope; San, ABS, EP42HT for pencil probe) are USP class VI.
Functionality as a pulsed Doppler ultrasound system	Device described to process and display ultrasound signals, indicating frequency shift when meeting a blood vessel, showing exact position and depth.
Software operating system	MS-Dos.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable / Not Provided: A dedicated "test set" in the context of a performance study with specific metrics (like sensitivity, specificity, accuracy) is not described. The 510(k) relies on comparison to predicate devices and adherence to safety standards.
Data Provenance: The acoustic output measurements were performed on the Hemo-Dop® device itself (implied to be in Germany, given the manufacturer's address). The claims of safety and effectiveness are based on design controls, comparison to predicate devices, and adherence to recognized standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable / Not Provided: As there is no described performance study with a test set requiring expert ground truth establishment for diagnostic accuracy, this information is not present. The "ground truth" for acoustic output measurements would be the physical measurements themselves.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: No test set or related adjudication method is detailed in this 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No: An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. The context is a device submission focused on substantial equivalence, not a detailed clinical comparative study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable / Not Provided: The Hemo-Dop® is a hardware device (ultrasound system with probes) that provides real-time information to a human operator. It is not an "algorithm only" device, so a standalone performance study in that context would not be relevant. The stated purpose is for medical professionals to detect blood vessels and assist in procedures.

7. The Type of Ground Truth Used

Process-Oriented / Scientific Measurement: The "ground truth" in this submission primarily revolves around engineering and safety parameters:
- Acoustic Output: Measured values against FDA recommended limits.
- Material Biocompatibility: Conformance to USP class VI standards for patient contact materials.
- Electrical Safety and EMC: Conformance to specified EN standards.
- Functional Description: How the device processes and displays ultrasound signals.
There is no mention of "expert consensus, pathology, outcomes data" as ground truth for a diagnostic performance claim in this summary.

8. The Sample Size for the Training Set

Not Applicable / Not Provided: This device is an ultrasound system, not a machine learning algorithm that requires a "training set" of data in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not Applicable / Not Provided: See point 8.

Summary

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DWI
-----

Hemo-Dop® 510 (k) Summary

Status: F

Valid from: 13-04-2004 Revision: 0 Page 1 of 2 File: FDA-Summary-for-Hemo-rev0.doc

K041915

Written by:	GW / EM
-------------	---------

Comments of the contract of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first and th

Date:	13-04-2004
-------	------------

Address of the property

510K Summary

ldentifying Information 1.

Manufacturer:	DWL Elektronische Systeme GmbH
Address:	Josef-Schuettler Str. 2D-78224 SingenGermany
Telephone:	+49 7731 79769 0
Fax:	+49 7731 79769 99
E-Mail:	info@dwl.de
Contact :	Gerold Widenhorn / Regulatory Affairs
Name of Device :	Hemo-Dop®

2. Class and Predicate Information
Classification Name:	Ultrasonic pulsed Doppler imaging system 892.1550
Common Name:	Ultrasound Doppler System
Proprietary Name:	Hemo-Dop®
Class:	Regulatory Class II
Predicate Device:	KOVEN TECHNOLOGY INC.; Model KM-25DWL Elektronische Systeme GmbH; Multi-Dop® L	K951449 K930458

Performance Standards 3.

None Performance Standards: Performance Standards.
Conforms to the following voluntary standards: EN60601-1, EN60601-1-1, EN60601-1-2

Indications for Use 4.

The Hemo-Dop® is a medical device to detect blood vessels supplying haemorrhoids and the subse-The Hemo-Dop® is a medical device to del blood resole osparis suced as useful supplement when doing quent HAL for haemornolds of state if and in. It can asso be assul as work opportunities in the used for measuring the Sciero-theraby and Banceries and veins subcutaneous.

Device Description 5.

The Hemo-Dop® consists of two parts. A proctoscope with implemented ultrasound probe and a basic The Hemo-Dop® consists of two parts. A proclosope in inserences in inserted in the recture of unit which processes and displays the ultrasound signals. The processes of 360° can be insonated. When the

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the letters "DWL" in a bold, sans-serif font. The letters are arranged horizontally, with "D" on the left, "W" in the middle, and "L" on the right. There are lines that appear to be part of a 3D design, giving the letters a sense of depth. The background is plain, which makes the letters stand out.

Status: F

ultrasound radiation meets a blood vessel, the frequency shift can be heard and it is graphically disultrasound Tablation mecle a blood Toooo, the Requeen in different deptration in flat played. With the bullent of the vessel but also the depth in which it hows. Through the user not only Knows the exact position of the vessel. Since in the area behind the linear the procloscope the user can logate the roose. The can be treated as outpatient of the black defitate the pattent doesn't ficed a general or lobal thabethesia and reliable evaluation of the blood flow signals of the extracranial and peripheral vessels.

General Safety and Effectiveness દ.

The Hemo-Dop® is similar to currently distributed pulsed Doppler ultrasound systems with prochoscope The remo-Dopo is similar to darrenty discribed is displayed in a FFT Maximum
including 8MHz probe and 8MHz pencil probe. The Doppler signal is displayed of the time Including own is under by the FDA recommended limit and power level is displayed all the time.

Following acoustic output parameters have been measured

8MHz Pencil Probe PW mode

	MaxValue	Power[mW]	fc[MHz]	ZSP[cm]	X-6,Y-6[cm]	PD[ $\mu$ s]	PRF[Hz]	EBD Az,Ele[cm,cm]
ISPTA.3(mW/cm²)	334	10.2	7.82	0.7	0.168,0.148	-	-	0.5,0.25
ISPTA.1(mW/cm²)	1.86	10.2	7.82	0.7	0.168,0.148	20	9000	-

toscone Probe PW mode

	MaxValue	Power[mW]	$f_c$[MHz]	$Z_{SP}$[cm]	X[cm]	Y[cm]	PD[ $\mu$ s]	PRF[Hz]	EBD Az, Ele[cm,cm]
ISPTA.3 (mW/cm²)	8.1	0.74	7.88	0.65	0.428	0.272			0.3,0.5
SPPA.3 (W/cm²)	0.04	0.74	7.88	0.65	0.428	0.272	20	9000

Patient Contact Material 7.

The material of the proctoscope which comes in contact with patient is:

Ligateur Tube	PMP	(USP class VI)
Ligateur Body and Handle	PPSU black	(USP class VI)
Epoxy Glue	EP42HT	(USP class VI)
Glue	Photobond 4442	(USP class VI)

The material of the Pencil probes which comes in contact with patient is:

Lens	San	(USP class VI)
Housing	ABS	(USP class VI)
Epoxy Glue	EP42HT	(USP class VI)

8. Software

The Hemo-Dop® operating system is MS-Dos.

9. Conclusion

In accordance with the FDA and based on the information provided in this Premarket notification, DWL m accordance with the PDA and based on that the Hemo-Dop is safe and effective and substantially equivalent to predicate devices described herein.

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		Hemo-Dop® 510 (k)
		Product Information	Valid from: 12 07 2004
			page 1 of 1
		Status: F	File: PI-Hemo-Indication-Use-rev1.doc

Written by:	GW / EM
Date:	12-07-2004

Indication of Use

The Hemo-Dop® is a medical device to detect blood vessels supplying haemorrhoids and the subse-The Hemo-Dop® is a medical device in deec biogram nature mature material supplement when doing quent HAL for haemormous of state if and in. It can also be assure as assume applied of the Sciero-therapy and Barron "igation" ifgature subcutaneously.

× Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

© Copyright DWL Elektronische Systemo GhbH - Nur für von DWL autorsiarle Personen!
Zustlandigkeiter V = Verantworlung, F = Mormation - Status: E = Entwurf, F = Freiggeben, U

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 resembling three stylized stripes or chevrons, which are meant to represent the agency's mission of promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

DWL Elektronische Systeme GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K041915

Trade Name: Hemo-Dop System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN and ITX Dated: July 14, 2004 Received: July 16, 2004

. . .

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your beenon 510(x) promotially equivalent (for the indications for use stated in above and we have determarked predicate devices marketed in interstate commerce prior to the enclosure) to regarly marketed production Device Amendments, or to devices that have been May 26, 1970, the charment date 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 may, includiv, manket the device, basyes it ins an age annual registration, listing of devices, good Controls provisions of thabeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Hemo-Dop System, as described in your premarket notification:

Transducer Model Number

8 MHz PW/CW (Proctoscope) 8MHz Pencil Probe

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be If your device is classinod (soc above) isting major regulations affecting your device can be found in the Sublet to subliations, 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 I least of a rised that your device complies with other requirements of the Act or any I DA has made a acternmances and inistered by other Federal agencies. You must comply with all the

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Page 2 - Mr. Preiss

Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); abeling (21 Act's requirements, including, but not mined of regisments as set forth in the quality systems (QS) CFR Part 801); good manufacturing practice requirements as sociation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the prior to shipping the first I his determination of substance special report should contain completed information, device, you submit a posiciearance special report. This devices, requested in Appendix G,
including acoustic output measurements based on production Marketing including acousine output measurements based on producturers Seeking Marketing (enclosed) of the Center 3 Scpennoer 30, 1997 - inventually of the special report is incomplete of Clearance of Diagnostic Uniasound Systems and Transastion approved levels), then the 5 10(k)
contains unacceptable values (e.g., acoustic output greater than approved levels contains unaceeplable values (c.g., accustie output ground may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and The special roport should be submitted in desubmitted 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. I his letter will anow you to ocenn hanceling 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 If you desire specific advice tor your de riod on our was times on the promotion and the Office of Comphance at (301) 594-4371. Taxationally, and (301) 594-4639. Also, please note advertising of your device, premarket notification" (21 CFR Part 807.97). the regulation entitied, "Misoralianing of responsibilities were the Act may be obtained from the Division of Other general intonnation on your responsibilities at its toll-free number (800) 638-2041 or at Sinall Manufacturers, 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 vours,

Nancy Brogdon

Nancy C. Broge Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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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				N	N
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Hemo-Dop® System

(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)

Nancy C. bassylor

(Division Sign-Off) (Division of Reproductive Division of Radiological Devices 510(k) Number _

F-3

{6}------------------------------------------------

Appendix F

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 Application	PWD	CWD
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	N	N
Transvaginal
Transurethral
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: Proctoscope with inbuild 8 MHz Transducer

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. Beagdon

(Division ominal. Division of Reproductive, and Radiological Dev 510(k) Number

F-3

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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	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 MHz Pencil Probe

(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)

Nancy C. Brogdon

(Division Sign-Off) (Division Sign-Om)
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number -

F-3

Regulation Number and Section

§ 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.