Quiver Laparoscopic Extendable

K153472 · Itl Corporation Pty, Ltd. · HAM · Jun 23, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153472
• Device Name: Quiver Laparoscopic Extendable
• Applicant: Itl Corporation Pty, Ltd.
• Product Code: HAM · General, Plastic Surgery
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

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

Device Story

Quiver Laparoscopic Extendable is a telescoping, cylindrical instrument holder designed for use in surgical settings. It consists of two components that allow the device to be collapsed for compact storage/disposal and extended to hold long surgical instruments. It features a loop handle for hanging. The device is non-active and intended for use by surgical staff to safely store electrosurgical diathermy units or other long instruments during procedures. It does not contact the patient. The device is provided sterile and is for single-use only.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual inspection, dimensional measurements, assembly inspection, extension/collapsing tests, application tests, drop tests, packaging integrity tests, and accelerated aging. Biocompatibility testing (hemocompatibility, cytotoxicity, sensitization, irritation, systemic injection) was performed despite the device being non-patient contact.

Technological Characteristics

Telescoping cylindrical holder; non-active; disposable material. Sterilization: ETO per ISO 11135:2007 (SAL 10^-6). Dimensions: ~9.5 inches collapsed, 15.75 inches extended. No electronic components or software.

Indications for Use

Indicated for use as a holder for electrosurgical diathermy system conducting units and/or other long surgical instruments during surgery. For single-use only.

Regulatory Classification

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.

Predicate Devices

• Modified Olsen Disposable Holster (K884172)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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FORM FDA 3881 (8/14)

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Image /page/3/Picture/2 description: The image shows the logo for ITL, which is a blue acronym surrounded by two curved yellow lines. The letters "ITL" are in a bold, sans-serif font. The yellow lines are positioned above and below the acronym, creating a semi-circular frame around it. The logo has a clean and professional design.

## 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: [phone] |
| | Fax: [phone] |
| | |

- 5.2 Contact Person: Emily B. Rossiter President, Regulatory Resources, Inc. Registered Agent for ITL 276 William Wav Williamsburg, VA 23185 [e-mail] Phone: [phone] Fax: [phone]
- 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.