HASKAL TORQUE DEVICE

K100425 · Elcam Medical Acal · DQX · Jun 17, 2010 · Cardiovascular

Device Facts

• Record ID: K100425
• Device Name: HASKAL TORQUE DEVICE
• Applicant: Elcam Medical Acal
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

Device Story

Haskal™ Torque Device is a sterile, single-use, one-piece molded vise-grip accessory; used to facilitate steering of guidewires during interventional procedures. Device features interlocking teeth; user squeezes sides to open a central groove, places guidewire (0.010 to 0.038 inches) inside, and releases to secure. Side-mounting design eliminates need for distal end threading; allows for repositioning during advancement. Physician rotates device to transmit torque to guidewire for steering. Device remains outside patient body; no blood contact. Benefits include improved ease of use and efficiency during guidewire manipulation.

Clinical Evidence

Bench testing only. Studies included packaging environmental endurance, dimensions verification, axial force, torque force, operational force, performance during fluid exposure, usability, sterility integrity, shelf life, and biocompatibility (cytotoxicity, systemic toxicity, sensitization, irritation, subchronic toxicity, genotoxicity, and hemolysis).

Technological Characteristics

One-piece molded vise-grip device; biocompatible materials; ETO sterilized. Accommodates guidewires 0.010-0.038 inches. Mechanical operation via manual squeeze-to-open, release-to-grip mechanism. No energy source or software.

Indications for Use

Indicated for use by clinicians to facilitate steering of guidewires during interventional procedures. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Guide Wire Torque Device (Merit Medical) (K072552)
• WireClip™ Torquer (Boston Scientific Corporation) (K003398)

Submission Summary (Full Text)

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# Section 5 Revised 510(k) Summary K100425

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Revised 510(k) Summary (K100425) – May 2010

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### 510(K) Summary

#### Haskal™ Torque Device 510(k) Number K100425

#### 1. Applicant's Name:

Elcam Medical ACAL. ..1.1.1 -Kibbutz BarAm MP Merom HaGalil 13860 ISRAEL Tel: [phone] Fax: [phone]

#### 2. Contact Person:

Name: Shay Shaham

Title: VP Quality and Regulatory Affairs

(+972) -4- 698-8098 Tel:

([phone] Fax:

E-mail: [e-mail]

#### 3. Trade Name:

Haskal™ Torque Device

#### 4. Classification:

| Name: | Guide wire torque |
|-----------------------|-------------------|
| Product Code: | DQX |
| Regulation No: | 870.1330 |
| Class: | II |
| Classification Panel: | Cardiovascular |

#### 5. Predicate Devices:

- > Guide Wire Torque Device (Merit Medical), catheter guide wire, product code DQX, cleared for marketing under K072552
- > WireClip™ Torquer (Boston Scientific Corporation), guide wire torquer, product code DQX, cleared for marketing under K003398

Revised 510(k) Summary (K100425) - May 2010

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#### 6. Intended Use:

The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

#### 7. Device Description:

The Haskal™ Torque Device is a one-piece molded unit with rows of interlocking "teeth". When the sides of the device are squeezed, the "teeth" line up and a groove is exposed in the center. The device is then positioned with the guidewire in the groove. When the sides are released, the device "teeth" close onto the guidewire to secure it firmly. The Haskal™ accommodates guidewires with diameters between 0.010 inches to 0.038 inches.

The Haskal™ is designed to be mounted onto the guidewire from the side with one hand, eliminating the need for threading along the wire starting from the distal end. It can also be released from the guide wire or repositioned as the guide wire advances by squeezing it on both sides to release the wire.

The Haskal™ is a sterile, non-pyrogenic single use device. It is manufactured in several colors.

#### 8. Technological Characteristics:

The Haskal™ technological characteristics are the same as those of its predicate devices. It is an accessory torque device for attaching to guidewires, is compatible for use with guidewires of varying types, diameters and lengths, and can be positioned and repositioned on the quidewire. Same as the predicates, rotating the device results in steering of the guidewire.

Identical to the predicates, Haskal™ is a sterile, non-pyrogenic single use device manufactured from biocompatible materials and sterilized by ETO.

Identical to the WireClip predicate, Haskal™ is a one-piece side-mounted vise grip device. loaded by squeezing with 2 fingers to create a groove in the device into which the quidewire is placed. Release of the squeeze action allows the groove to close around the guidewire securing and firmly gripping it.

#### 9. Summary of Supporting Data:

The Haskal™ Torque Device performance characteristics were evaluated in the following in-vitro/bench studies:

- Packaging Environmental Endurance
- · Dimensions Verification
- · Device and Guidewire Axial Force
- · Torque Force
- · Device Operational Force
- · Performance During Exposure to Fluids
- · Usability
- · Sterility Integrity and Shelf life

Revised 510(k) Summary (K100425) - May 2010

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- . Biocompatibility:
- Cytotoxicity .
- Systemic toxicity .
- Sensitization .
- . Irritation
- . Subchronic toxicity
- Genotoxicity .
- Haemocompatibility- Hemolysis .

The torquer device remains outside the patient's body during the medical procedures and there is no contact with the blood. Therefore the Hemolysis test we perform is additional for the requirement of this device.

Results of nonclinical testing demonstrated that the device is as safe, as effective, and performs as well as the legally marketed devices identified in paragraph 5 of this section.

#### 10. Conclusion:

Elcam Medical believes that, based on the information provided in this submission, the Haskal™ Torque Device is substantially equivalent to its predicate devices without raising any new safety or effectiveness issues.

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

JUN 1 7 2010

Elcam Medical, Inc. c/o Mr. Lloyd Fishman President 2 University Plaza, Suite 620 Hackensack, NJ 07601

Re: K100425

> Trade/Device Name: Haskal™ Torque Device Common Name: Wire, Guide, Catheter Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: June 6, 2010 Received: June 10, 2010

Dear Mr. Fishman:

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 II (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 (21

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#### Page 2 - Mr. Lloyd Fishman

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Vahner

Image /page/5/Picture/7 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and somewhat illegible, with looping strokes and a horizontal line intersecting the bottom portion. The overall impression is that of a quick, cursive signature.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K100425 |
|---------------------------|-----------------------|
| Device Name: | Haskal™ Torque Device |

**Indications for Use:**

The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

| Prescription Use | X | OR | Over the Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number_K100426

Duna R. Vines

(Division Sign-Off) Division of Cardlovascular Devices

510(k) Number K100425