The HAL Scope Holder System is intended for use during medical procedure where sterile barrier is required on manipulating/ movable arms. It is for single use only.

Device Description

The HAL Scope Holder System is used to provide a sterile barrier for re-usable manipulating arm. The disposable cover includes a sterile quick release scope adapter and sterile drape assembly. The device will be installed to an existing re-usable manipulating arm before a medical procedure to act as a barrier between the sterile field and the non-sterile re-usable manipulating arm. The device is single use only and can be used with Noved Medical Universal Arm.

AI/ML Overview

The provided document describes the HAL Scope Holder System, a surgical drape, and its 510(k) submission for substantial equivalence to a predicate device. The information focuses on the physical and technical comparison of the device and does not involve AI or machine learning. Therefore, many of the requested fields related to AI model evaluation, ground truth, and expert studies are not applicable.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Technological Equivalence to Predicate Device:	Met:
Similarity of Materials (polyethylene film)	Noved Medical drapes are constructed primarily of polyethylene film heat-sealed to a tip attachment.
Construction (heat-sealed polyethylene film)	The predicate device and the HAL Scope Holder System are constructed using heat-sealed polyethylene film.
Packaging (form, peel and seal pouches, Gamma sterilization, 10^-6 SAL)	The HAL Scope Holder System is packaged in form, peel and seal pouches and is sterilized through Gamma sterilization. Both the new device and the predicate device maintain a sterilization assurance level of 10^-6 SAL.
Material Properties:	Met:
Strength of polyethylene film	Determined to be acceptable. (Specific quantitative data not provided, but deemed acceptable for the application).
Elongation of polyethylene film	Determined to be acceptable. (Specific quantitative data not provided, but deemed acceptable for the application).
Appearance and Handling:	Met:
Similar to predicate device	Based on appearance and handling evaluations, the HAL Scope Holder System is similar to the predicate device.
Barrier Testing:	Not Applicable:
Determined not applicable based on Biocompatibility Flow Chart (ISO-10993 guidelines memo dated May 1, 1995).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The evaluations are described qualitatively (e.g., "based on strength and elongation," "based on appearance and handling evaluations"). These likely refer to mechanical and material tests rather than a "test set" in the context of an AI model.
Data Provenance: Not explicitly stated, however, the assessments are internal evaluations conducted by Noved Medical, Inc. (the manufacturer).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a surgical drape, and its evaluation does not involve ground truth established by medical experts in the way an AI diagnostic tool would. The "truth" is based on material properties and functional equivalence.

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

Not applicable. No adjudication method described for this type of device evaluation.

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:

Not applicable. This device is a physical surgical drape, not an AI-powered tool.

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

Not applicable. This device is a physical surgical drape, not an AI algorithm.

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

Not applicable in the context of typical AI model evaluation. For this device, the "ground truth" or basis for acceptance is derived from:
- Material specifications and established standards: Polyethylene film properties, sterilization assurance levels (SAL).
- Functional equivalence: Comparison of physical attributes and handling characteristics to a legally marketed predicate device.
- Regulatory guidelines: Adherence to ISO-10993 for biocompatibility assessment.

8. The sample size for the training set:

Not applicable. There is no AI model involved, thus no training set.

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

Not applicable. There is no AI model involved, thus no training set or ground truth for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the HAL Scope Holder System meets its acceptance criteria is a non-clinical evaluation focused on demonstrating substantial equivalence to an existing predicate device (Hydromed Product's Universal Drape) and confirming acceptable material properties.

The key aspects of this study include:

Technological Comparison: The device was compared to the predicate based on:
- Similarity of Materials: Both use polyethylene film.
- Construction: Both use heat-sealed polyethylene film.
- Packaging and Sterilization: Both use form, peel and seal pouches and Gamma sterilization, maintaining a Sterilization Assurance Level (SAL) of 10^-6.
Performance Data (Non-Clinical Evaluations):
- Appearance and Handling: The HAL Scope Holder System was evaluated to be "similar to the predicate device" based on these subjective assessments.
- Material Strength and Elongation: The polyethylene film's strength and elongation were "determined to be acceptable." While specific quantitative data for the HAL system is mentioned, it is noted that predicate data was not available, implying this was an internal standard assessment.
Barrier Testing: This was deemed "not applicable" after reviewing the Biocompatibility Flow Chart (matrix) included in ISO-10993 guidelines memo dated May 1, 1995. This indicates a regulatory-driven decision based on established international standards, not a lack of performance.

Conclusion of the Study:

The study concluded that, "Based on all physical performance comparisons, the HAL Scope Holder System will function effectively and comparable to the Universal Camera Drape marketed by Hydromed Products." This conclusion was sufficient for the FDA to determine substantial equivalence and allow the device to be marketed.

Summary

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JUN 23 1

JUN 2 3 1999

510(K) SUMMARY HAL SCOPE HOLDER SYSTEM

Date:	April 9,1999
Owner/Operator:	Noved Medical, Inc.
Contact Person:	Mike GriffinVice President of OperationsNoved Medical, Inc.
Device Trade Name:	HAL Scope Holder System
Common Name:	Surgical Drape
Classification Name:	Surgical Drape and Drape Accessories
Regulatory Reference :	79KKX
Predicate Device:	Hydromed Product's Universal Drape

Description:

Intended Use:

The HAL Scope Holder System is intended for use during a medical procedure where sterile barrier is required on manipulating / movable arms.

Physical/Technical Comparison:

Technological Comparison: The Noved HAL Scope Holder System is technologically equivalent to the drape marketed by Hydromed Products based on the following:

Similarity of Materials: Noved Medical drapes are constructed primarily of polyethylene film heat a) sealed to a tip attachment.
Construction: The predicate device and the HAL Scope Holder System are constructed using b) heat sealed polyethylene film.
C) Packaging: The HAL Scope Holder System are packaged in form, peel and seal pouches and is sterilized through Gamma sterilization. Both the new device and the predicate device maintain a sterilization assurance level of 10-6 SAL.

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Performance Data:

Non-Clinical Evaluations: Based on appearance and handling evaluations, the HAL Scope Holder System is similar to the predicate device.

Clinical Evaluation: Based on the strength and elongation of the polyethylene film used in the HAL Scope Holder System, the material used for the new device was determined to be acceptable. (Data for the predicate device is not available).

Barrier testing was determined not to be applicable for the HAL Scope Holder System. Determination was made after reviewing the Biocompatibility Flow Chart (matrix) included in ISO-10993 guidelines memo dated May 1, 1995.

Conclusion: Based on all physical performance comparisons, the HAL Scope Holder System will function effectively and comparable to the Universal Camera Drape marketed by Hydromed Products.

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Image /page/2/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 that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Mr. Mike Griffin Vice-President of Operations Noved Medical, Incorporated 168 Avenida Del Mar, Suite 120 San Clemente, California 92672

Re : K991548 HALTM Scope Holder System Trade Name: Requlatory Class: II Product Code: KKX Dated: April 9, 1999 Received: May 3, 1999

Dear Mr. Griffin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Griffin

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991548

Device Name: HAL Scope Holder System

Indication For Use:

The HAL Scope Holder System is intended for use during medical procedure where sterile barrier is required on manipulating/ movable arms.

It is for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

(Per CFR 801.109)

Over the Counter Use

Qlin S. Lin

(Division Sign-Off Division of Dental, Info and General Hospit i ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.