(204 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
No
The device is a holder for surgical instruments, not a device that directly provides therapy to a patient.
No
The device description indicates it is a holder for surgical instruments, and the intended use states it is for holding instruments during surgery. Neither the 'Intended Use' nor the 'Device Description' mention any diagnostic function such as capturing or analyzing data for diagnosis.
No
The device description clearly describes a physical, telescoping instrument holder made of materials that undergo physical testing and sterilization validation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold surgical instruments during surgery. This is a procedural aid used directly in the surgical environment.
- Device Description: The description details a physical holder for instruments, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on the physical properties of the device (material compatibility, assembly, extension/collapsing, drop test, sterilization), which are relevant to a surgical instrument holder, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single-use only.
Product codes
HAM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
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)
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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.