The Quiver Laparoscopic Extendable is a telescoping instrument holder comprised of two separate parts. One component (the outer or top component) has two open ends and the other component has one open end and one closed end. It is provided assembled and sterile, allowing compact storage and shipment then extension by the user to hold long surgical instruments. After use, the device can be collapsed for compact disposal. A loop handle attached to the top can be used for hanging the device in a convenient place.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Quiver Laparoscopic Extendable." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets a specific set of acceptance criteria through a full-scale clinical trial in the way a novel AI algorithm might. Therefore, many of the requested items related to "study" and "ground truth" are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific quantitative thresholds that the device was required to meet, as would be typical for an AI algorithm. Instead, it lists various evaluations and tests conducted to ensure the device's safety and functionality in comparison to a predicate device. The performance is described qualitatively.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Functional Performance:
- Ability to Extend/Collapse	Passed Extension/Collapsing Test
- Ability to Hold Instruments	Passed Application Test
- Durability/Resistance to Damage (e.g., from drops)	Passed In-house Drop Test
Material Properties:
- Biocompatibility (hemocompatibility, cytotoxicity, sensitization, irritation, systemic injection)	Tested (Note: device is not patient contact, but materials were evaluated)
- Thermal Resistance (inferred, as suitable for heat-conducting instruments)	Made of material with "stiffness and thermal resistance properties suitable for heat-conducting surgical instruments"
Sterilization Efficacy:
- Sterility Assurance Level 10^-6	ETO sterilization method validated according to ISO 11135:2007 Sterilization of Health Care Products with SAL specification 10^-6
Physical Integrity/Quality:
- Conformance to Design Specifications (dimensions, assembly)	Visual inspection and dimensional measurement of all molded components. Full assembly physical inspection and measurement.
- Packaging Integrity	Passed Packaging Integrity Test
- Shelf Life/Stability over time	Accelerated aging test conducted (real-time aging test ongoing)
Risk Management:
- Identification and Mitigation of Risks	Risk evaluation conducted in accordance with EN ISO 14971:2012 and EN 62366:2008. Mitigation measures defined and implemented for all potential risks associated with design, usability, manufacturing, storage, and intended use.

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

The document does not specify a distinct "test set" in the context of clinical data for an AI/algorithm, as this is a physical medical device. The "tests" performed (e.g., Extension/Collapsing Test, Drop Test, Packaging Integrity Test) would involve a sample size of the manufactured device units, but these specific numbers are not provided.

The "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven device.

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

Not applicable. This device does not involve expert-established ground truth in the way an AI diagnostic tool would. The ground truth for functional product testing is typically based on engineering specifications and validated test methods.

4. Adjudication method for the test set

Not applicable. There's no adjudication in the sense of expert review for diagnostic agreement in this context.

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 is a physical instrument holder, not an AI-assisted diagnostic or treatment device.

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

Not applicable. This is a physical instrument holder, not an algorithm.

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

The "ground truth" in this context is based on:

Engineering Specifications: For dimensional measurements, assembly, and functional parameters.
International Standards: Such as ISO 11135:2007 for sterilization validation, and EN ISO 14971:2012 for risk management.
Material Science Principles: For biocompatibility and thermal resistance.
Internal Quality Control Procedures: For visual inspection and various in-house tests.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve AI model training.

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

Not applicable. This is a physical device and does not involve AI model training.

Summary of the Study (Performance Data):

The document describes the following evaluations and tests performed on the Quiver Laparoscopic Extendable:

Visual inspection and dimensional measurement of all molded components: To ensure parts meet design specifications.
Full assembly physical inspection and measurement: To verify proper assembly and final dimensions.
Extension/Collapsing Test: To confirm the device's ability to extend and collapse as intended.
Application Test: To verify its function as an instrument holder.
In-house Drop Test: To assess the device's durability under typical handling conditions.
Packaging Integrity Test: To ensure the sterility barrier and physical protection of the device during transport and storage.
Accelerated aging test (real-time aging test ongoing): To predict shelf-life and material stability over time.
Biocompatibility testing: For hemocompatibility, cytotoxicity, sensitization, irritation, and systemic injection of the material, even though it's not a patient-contact device.
ETO sterilization method validation: According to ISO 11135:2007 Sterilization of Health Care Products, achieving a Sterility Assurance Level (SAL) of 10^-6.
Risk evaluation: Conducted in accordance with EN ISO 14971:2012 (Risk Management) and EN 62366:2008 (Usability Engineering), leading to the definition and implementation of mitigation measures for identified risks.

The overall "study" is a collection of engineering and material verification tests aimed at demonstrating that the device is safe and performs as intended, and importantly, is substantially equivalent to the predicate device. These tests, rather than a clinical trial, are the basis for the FDA's 510(k) clearance for this type of device.

Summary

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

June 23, 2016

ITL Corporation Pty Ltd % Ms. Emily Rossiter President Regulatory Resources, Inc. 276 William Way Williamsburg, Virginia 23185

Re: K153472

Trade/Device Name: Quiver Laparoscopic Extendable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: HAM Dated: November 30, 2015 Received: December 2, 2015

Dear Ms. Rossiter:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153472

Device Name

Quiver Laparoscopic Extendable

Indications for Use (Describe)

Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single-use only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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510(k) Notification For QUIVER LAPAROSCOPIC EXTENDABLE (A100604)

5: 510k Summary

5.1 510k Submitter,	ITL Corporation Pty Ltd
	Sponsor & Owner: 1/63 Wells Road, Chelsea Heights
	Victoria, Australian Capital Territory, 3196
	Australia
	Phone: 61-3-8773-3050
	Fax: 61-3-8773-3059

5.2 Contact Person: Emily B. Rossiter President, Regulatory Resources, Inc. Registered Agent for ITL 276 William Wav Williamsburg, VA 23185 rri@infionline.net Phone: 804-370-9459 Fax: 757-277-0212
5.3 Date of Summary: June 22, 2016

5.4 Device

5.4.1 Trade Name: Quiver Laparoscopic Extendable
5.4.2 Common or Usual Name: Laparoscopic Instrument Holder
5.4.3 Classification Name: Apparatus, Electrosurqical (Accessory) 21 CFR 878.4400
5.4.4 Requlatory Class : 2
5.4.5 Device Product Code: HAM

5.5 Predicate Device: Modified Olsen Disposable Holster, K884172 This product has not been subject to a design-related recall.

5.6 Device Description: The Quiver Laparoscopic Extendable is a telescoping instrument holder comprised of two separate parts. One component (the outer or top component) has two open ends and the other component has one open end and one closed end. It is provided assembled and sterile, allowing compact storage and shipment then extension by the user to hold long surgical instruments. After use, the device can be collapsed for compact disposal. A loop handle attached to the top can be used for hanging the device in a convenient place.

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5.7 Indications for Use: Holder for electrosurqical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

5.8 Comparison of Technological Characteristics with the Predicate Device:

Both holders are simple non-active containers made of disposable material with stiffness and thermal resistance properties suitable for heat-conducting surgical instruments. The Modified Olsen Holster is rectanqular in shape with rounded corners and a lid: its length is 6¼ inches. The Quiver Laparoscopic Extendable is cylindrical in shape with a loop on the top of the holder that can function as a hanger. It has no lid. lts length is approximately 9½ inches collapsed and 15¾ inches extended. The two holders have a top opening of similar size for insertion of instruments. Neither holder is intended for patient contact.

5.9 Performance Data: The Quiver Laparoscopic Extendable is made of material that has been tested for hemocompatibility, cytotoxicity, sensitization, irritation and systemic injection although the Quiver is not a patient contact device. The device has undergone evaluation and testing that includes:

Visual inspection and dimensional measurement of all moulded components ●
. Full assembly physical inspection and measurement
. Extension/Collapsing Test
. Application Test
. In-house Drop Test
. Packaging Integrity Test
. Accelerated aging test (real time aging test ongoing)

The ETO sterilization method for the Quiver Laparoscopic Extendable has been validated according to ISO 11135:2007 Sterilization of Health Care Products with SAL specification 10-6.

5.10 Conclusions: Quiver Laparoscopic Extendable is substantially equivalent to the predicate device, as both have the same intended use and functional characteristics. Any safety or effectiveness concerns arising from differences between the two devices have been addressed through performance testing. A risk evaluation of the Quiver Laparoscopic Extendable has been conducted in accordance with EN ISO 14971:2012, Application of Risk Management to Medical Devices, and EN 62366:2008, Usability Engineering File. Mitigation measures have been defined and implemented for all potential risks identified to date that are associated with the design, usability, manufacturing, storage and intended use of the device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.