EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1

K131721 · Comed Medical Systems Co., Ltd. · LNS · Jul 22, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K131721
• Device Name: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
• Applicant: Comed Medical Systems Co., Ltd.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Jul 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GEMSS UROCAMP ASADAL-M1, Extracorporeal Shockwave Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.

Device Story

ASADAL-M1 is an electromagnetic extracorporeal shock wave lithotripter (ESWL) used to treat urinary calculi. System components include a shockwave generator, motorized floating treatment table, operator control console, and water circulation subsystem. Operation involves electrical impulses sent through an inductance coil to generate a magnetic field, repulsing a metallic membrane to create acoustic impulses; these are focused by an acoustic lens to form shock waves. The device integrates with a C-arm X-ray fluoroscope and ultrasound imaging unit for stone localization. Operated by physicians in a clinical setting, the system allows for X, Y, and Z-axis table adjustments to align the shockwave focus with the patient's stone. The output is the mechanical fragmentation of stones, facilitating their passage. Benefits include non-invasive treatment of renal and ureteral calculi.

Clinical Evidence

Clinical investigation conducted at two sites with 200 patients (142 male, 58 female). Follow-up occurred at one and two weeks. No patients received general anesthesia. Results indicated the device is safe with no reported complications or device malfunctions during the study period.

Technological Characteristics

Electromagnetic shockwave generator; lens focusing type. Motorized floating table (DC 24V motor). Imaging via C-arm X-ray (Thales TH9428 I.I., Varian ROTOR tube) and ultrasound. PLC-based control console with Pentium IV PC. Water circulation system for cooling and transmission. Complies with EN60601-1, EN60601-1-1, EN60601-1-2, EN60601-1-3, EN60601-2-7, EN60601-2-28, EN60601-2-32, EN60601-2-36, EN60601-1-4, and EN60601-1-6.

Indications for Use

Indicated for fragmentation of kidney stones (renal calyx and pelvic) and upper, middle, and lower ureteral stones in adult patients. Prescription use only.

Regulatory Classification

Identification

An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.

Special Controls

*Classification.* Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)

Predicate Devices

• EM-9000 (K101482)
• Lite-Med LM-9200 EOLMA (K103217)

Submission Summary (Full Text)

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# 510(k) Summary

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the GEMSS UROCAMP Medical Systems Co., Ltd., ASADAL-M1 Extracorporeal Shock Wave Lithotripter.

# 1. Company making the submission (Owner):

| Name: | GEMSS UROCAMP |
|--------------------|---------------------------------------------------------------------------|
| Address: | 236-4 Sangdaewon-dong<br>Jungwon-gu<br>Seong nam-si<br>Gyeonggi-do, Korea |
| Telephone:<br>Fax: | 82-31-737-2211<br>82-31-737-2210 |
| Contact: | Iksoo Kim |
| E-Mail | kimiksoo@GEMSS UROCAMP.co.kr |

# 2. Device Name and Classification:

| Trade/Proprietary Name: | Extracorporeal Shock Wave Lithotripter<br>ASADAL-M1 |
|-------------------------|-----------------------------------------------------|
| Common/Usual Name: | Extracorporeal Shock Wave Lithotripter |
| Regulation Number: | 876.5990 |
| Product Code: | LNS |
| Device Class: | II |

# 3. Predicate Devices:

Primary Predicate device is the EM-9000 [K101482], Elite Medical Inc., Atlanta, GA. The associate Predicate device is the Lite-Med LM-9200 EOLMA, [K103217], Lite-Med, Inc., and Taipei City, Taiwan.

# 4. Indications:

The GEMSS UROCAMP ASADAL-M1, Extracorporeal Shockwave Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.

CAUTION: Federal law restricts this device to sale, distribution, and use only upon the lawful order of a physician trained and/or experienced in the use of this device as outlined in an appropriate training program.

Delphi Consulting Group

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#### Description of Device:

The GEMSS UROCAMP Medical Systems Co., Ltd., ASADAL-M1 is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, and flexibility. The ASADAL-M1 device consists of a Shockwave Generator, an operator interface panel, and a water circulation subsystem. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance soil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shock waves and cooling of the generator. For the ESWL operation to be fully functional, two or three subsystems are provided. The first is a special treatment table. The second and third are a C-arm X-ray fluoroscope and an ultrasound imaging unit. The treatment table is a motorized floating table which can be moved in all three axes.

- 5. The Patient Table controls allow movement in the X, Y, and Z plain to adjust the focus of generating shockwave to patients' stones.

| Driving gear | DC 24V Motor |
|-------------------------------|-----------------------------------|
| Driving power | Single phase ~220-230VAC, 50/60Hz |
| Up and down movement | Elevator type |
| Right and left Movement range | 150mm |
| Front and rear Movement range | 150mm |
| Up and down movement range | 300mm |
| Product size | 2120 * 760 * 800 |
| Weight | 150kg |

- 6. Patient table
7. The control console to include treatment parameter,

| Control Type | PLC Controller control type |
|--------------|--------------------------------------|
| Power in use | Single phase ~220-230VAC,<br>50/60Hz |
| Monitor | Over 22" Wide |
| PC | Pentium IV |
| Product size | 820 * 715 * 890 |
| Weight | 150kg |

Sec 5 Summary doc Delphi Consulting Group Houston, TX 7707

Section 5 510(k) Submission Page #

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| 8. The shockwave generator/shock plug longevity (the number of s | |
|------------------------------------------------------------------|----------------------------------------------------|
| Generating<br>principle | Electro Magnetic Type |
| Focusing type | Lens focusing type |
| Input Voltage | 0 ~ 220VAC |
| Output Voltage | 0 ~ 20KVDC Step-by-step electric discharge |
| Control method | Auto / Manual |
| Discharge cycle | 0.6 ~ 10 second (recommend cycle is 1.0<br>second) |
| Replacement<br>cycle | 1.000.000 |

9. The water system,

| Control Type | IN /OUT Water Pump Type |
|-------------------|-------------------------|
| Water capacity | 10Liter |
| Replacement cycle | 3 months |

10. The localization/imaging system, and

| Controller | EMVIEW |
|------------|-----------------------------------------------------|
| I.I | 9" I.I(Thales (TH9428)) |
| TUBE | ROTOR Varian (Rad-99 / OR III) |
| KV RANGE | 40~120KV |
| MA RANGE | 0~5mA, 20mA |
| Camera | 1024 x 1024 Digital Camera<br>Digital Zoom 6", 4.5" |
| Lens | F 1.2 / 4mm |

# 11. Review of the Technological Characteristics of the device compared to predicate devices:

The ASADAL-M1 and the Primarily Predicate [K101482], and Secondary Predicate [K103217], devices have common Indications for Use, method of construction, method of operation, and design specifications. The technological characteristics of the shock wave are common to all as described in the consensus standard IEC 61846. The results are found similar to the predicate devices characteristics. The ASADAL-M1 device is two separate units, with operator controls in a separate but connected roll around assembly.

- 12. Clinical Studies:
ac 5 Summary doc Iphi Consulting Group Houston, TX 770

Section 5 510(k) Submission Page #

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The clinical investigations were performed at two sites with one and two week follow-ups to support this application. The patient population was 142 male and 58 females. None of the patients received general anesthesia.

The experiences of physicians have shown that patients treated by the ASADAL-M1 are safe and without follow-up complications. No incidence of device malfunction appeared in these clinical investigations.

#### 13. Safety Testing:

GEMSS UROCAMP ASADAL-M1. Extracorporeal Shockwave Lithotripter has been tested to the following International Standards with positive outcomes.

| Standards № | Standards Title |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN60601-1 | Medical electrical equipment Part 1: General requirements for<br>safety |
| EN60601-1-1 | Medical electrical equipment Part 1-1: General requirements for<br>safety-Collateral standard: Safety requirements for medical<br>electrical systems |
| EN60601-1-2 | Medical electrical equipment Part 1-2: General requirements for<br>basic safety and essential performance-collateral standard:<br>Electromagnetic compatibility-Requirements and tests |
| EN60601-1-3 | Medical electrical equipment Part 2: particular requirements for<br>the safety of high- voltage generators of diagnostic X-ray<br>generator |
| EN60601-2-7. | Medical electrical equipment Part 2: particular requirements for<br>the safety of high- voltage generators of diagnostic X-ray<br>generator |
| EN60601-2-28 | Medical electrical equipment Part 2: particular requirements for<br>the safety of X-ray source assemblies and X-ray tube<br>assemblies for medical diagnosis |
| EN60601-2-32 | Medical electrical equipment<br>Part 2: Particular requirements for the safety of associated<br>equipment of X-ray equipment |
| EN60601-2-36 | Medical electrical equipment Part 2: particular requirements for<br>the safety of equipment for extra corporeally induced lithotripsy |
| EN60601-1-4 | Medical electrical equipment Part 1-4: General requirements for<br>safety-Collateral standard: Programmable electrical medical<br>systems |
| EN60601-1-6 | Medical electrical equipment Part 1-6: General requirements for<br>safety-Collateral standard: Usability |

14. Rx or OTC:

The GEMSS UROCAMP ASADAL-M1, Extracorporeal Shockwave Lithotripter is a Rx prescription device per 21 CFR Subpart D.

Sec 5 Summary doc Belohi Consultino Group ston. TX 77071

Section 5 510(k) Submission Page #

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# 15. Conclusions:

From a clinical perspective and comparing design specifications, the ASADAL-M1 is substantially equivalent to the predicate devices. The ASADAL-M1 meets the FDA requirements stated in "Guidance for the Content of Premarket Notifications 510(k)s for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi." GEMSS UROCAMP Medical believes the minor differences of the ASADAL-M1 and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.

Sec 5 Summary doc Delphi Consulting Group Houston, TX 77071

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

#### Public Health Service

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

July 22, 2014

COMED Medical Systems % J. Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071

Re: K131721

Trade/Device Name: Extracorporeal Shock Wave Lithotripter, ASADAL-MI Regulation Number: 21 CFR\$ 876.5990 Regulation Name: Lithotripter, Extracorporeal Shock-Wave, Urological Regulatory Class: Class II Product Code: LNS Dated: June 20. 2014 Received: June 19.2014

Dear J. Harvey Knauss,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - J. Harvey Knauss

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDeyices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/6/Picture/8 description: The image shows the name "Benjamin Fisher -S" in a bold, sans-serif font. The letters in the middle of the name have a decorative, outlined design, while the rest of the letters are solid black. The name appears to be a logo or a stylized signature.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K131721

Device Name

GEMSS UROCAMP ASADAL-MI, Extracorporcal Shockwave Lithotripter

#### Indications for Use (Describe)

The GEMSS UROCAMP ASADAL-M1. Extracorporeal Shockwave Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY 12-11-11-11-11-11 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Benjamin R. 2014.07.22 1