HEMO-DOP

K041915 · Dwl Elektronische Systeme GmbH · IYN · Aug 4, 2004 · Radiology

Device Facts

• Record ID: K041915
• Device Name: HEMO-DOP
• Applicant: Dwl Elektronische Systeme GmbH
• Product Code: IYN · Radiology
• Decision Date: Aug 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Hemo-Dop® is a medical device to detect blood vessels supplying haemorrhoids and the subsequent HAL for haemorrhoids. It can also be used for measuring the Sclero-therapy and arteries and veins subcutaneous.

Device Story

Hemo-Dop® is an ultrasonic pulsed Doppler imaging system; consists of a proctoscope with an integrated ultrasound probe and a base unit. Device inputs ultrasound signals; processes and displays frequency shifts to identify blood vessel position and depth. Used in clinical settings for outpatient procedures; allows physicians to locate vessels for ligation without general or local anesthesia. Provides audible and graphical feedback of blood flow; assists in surgical planning and treatment of hemorrhoids and peripheral vascular assessment. Benefits include minimally invasive vessel localization and reduced need for anesthesia.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of acoustic output measurements (ISPTA, SPPA, frequency, power) for 8MHz pencil and proctoscope probes, confirming compliance with FDA safety limits for diagnostic ultrasound.

Technological Characteristics

Ultrasonic pulsed Doppler system. Materials: PMP (Ligateur tube), PPSU (Body/Handle), Epoxy EP42HT, Photobond 4442, ABS (Pencil housing). 8MHz probe frequency. Connectivity: Standalone. Standards: EN60601-1, EN60601-1-1, EN60601-1-2. Software: MS-DOS based.

Indications for Use

Indicated for detection of blood vessels supplying hemorrhoids, subsequent Hemorrhoidal Artery Ligation (HAL), and measurement of subcutaneous arteries and veins. Intended for prescription use.

Regulatory Classification

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.

Predicate Devices

• KOVEN TECHNOLOGY INC.; Model KM-25 (K951449)
• DWL Elektronische Systeme GmbH; Multi-Dop® L (K930458)

Submission Summary (Full Text)

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| DWI |
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# 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 |
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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

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| Date: | 13-04-2004 |
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Address of the property

# 510K Summary

#### ldentifying Information 1.

| Manufacturer: | DWL Elektronische Systeme GmbH |
|------------------|------------------------------------------------------|
| Address: | Josef-Schuettler Str. 2<br>D-78224 Singen<br>Germany |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| 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-25<br>DWL Elektronische Systeme GmbH; Multi-Dop® L | K951449<br>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

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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

| | Max<br>Value | Power<br>[mW] | fc<br>[MHz] | ZSP<br>[cm] | X-6,Y-6<br>[cm] | PD<br>[ $\mu$ s] | PRF<br>[Hz] | EBD Az,Ele<br>[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

| | Max<br>Value | Power<br>[mW] | $f_c$<br>[MHz] | $Z_{SP}$<br>[cm] | X<br>[cm] | Y<br>[cm] | PD<br>[ $\mu$ s] | PRF<br>[Hz] | EBD Az, Ele<br>[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 [phone]. Taxationally, and [phone]. 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 [phone] 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 [phone].

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | | |
| 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

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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 | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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 | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| 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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| 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