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.

AI/ML Overview

The provided text describes the Haskal™ Torque Device, a medical device intended to facilitate steering of guidewires during interventional procedures. The text primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k) K100425).

Here’s an analysis of the acceptance criteria and the study information based on the provided text, while explicitly noting what information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present specific numerical acceptance criteria (e.g., minimum torque force, maximum operational force thresholds) or corresponding reported performance values in a table. It states that "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," implying that the device met internal or regulatory expectations for each test.

The studies performed are listed as:

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
Biocompatibility (Cytotoxicity, Systemic toxicity, Sensitization, Irritation, Subchronic toxicity, Genotoxicity, Haemocompatibility- Hemolysis)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document repeatedly refers to "in-vitro/bench studies," which typically involve a certain number of units or measurements, but these numbers are not provided.
Data provenance: Not specified, other than being "in-vitro/bench studies." It does not mention country of origin, nor whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to the type of studies described. The "Haskal™ Torque Device" is a mechanical tool used to manipulate guidewires. Its performance is evaluated through bench testing (e.g., force measurements, usability assessment), not by interpretation of images or patient data requiring expert clinical judgment as "ground truth." Therefore, there were no experts establishing ground truth in the sense of clinical diagnoses or interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in studies where human readers or experts are disagreeing on interpretations (e.g., image readings). Since this device underwent bench testing, not a reader study, no adjudication method was relevant or performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. The document describes laboratory bench testing and mechanical performance evaluation for a physical medical device (a torque device), not an AI algorithm or an imaging diagnostic tool. Therefore, an MRMC study was not conducted.
Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

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

Standalone performance: Not applicable. The Haskal™ Torque Device is a physical, hand-operated tool. It is not an algorithm, and it always functions with human interaction to "steer guidewires." The "performance" described refers to the mechanical and physical characteristics of the device itself (e.g., torque force, operational force, biocompatibility), which are inherently "standalone" in the sense that they are properties of the device, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as clinical diagnosis or outcomes data is not applicable to this device's evaluation. For mechanical device testing, the "ground truth" would be established by:

Reference standards for dimensions and material properties.
Calibrated instruments for measuring forces (axial, torque, operational).
Standardized protocols for evaluating usability.
Laboratory tests (e.g., ISO standards) for biocompatibility and sterility.
Essentially, the ground truth is derived from objective, quantifiable measurements against established engineering and safety standards.

8. The sample size for the training set

Not applicable. The Haskal™ Torque Device is a physical medical device. It does not involve any artificial intelligence or machine learning component, therefore there are no "training sets" in the context of an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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Section 5 Revised 510(k) Summary K100425

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: (+972)-4-698-8120 Fax: (+972)-4-698-0777

2. Contact Person:

Name: Shay Shaham

Title: VP Quality and Regulatory Affairs

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

(+972) 4-632-0777 Fax:

E-mail: shay.shaham@elcam.co.il

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™ 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.