(49 days)
The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and Endo Vue devices. The device can operate on up to 9 channels.
This submission (K131115) is for a firmware modification to the existing ZeroWire Duo Wireless HD Video Transfer System (predicate device K100195), increasing the number of available channels from 3 to 9. The document states that clinical data is not needed for this type of wireless device according to 510(k) submission guidance. However, the submission does include test results in a clinical environment to demonstrate substantial equivalence to the predicate device.
Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted based on the provided information, which focuses on demonstrating equivalence rather than establishing new performance criteria for a novel device. The "acceptance criteria" here would be the successful demonstration of performance, safety, and effectiveness equivalent to the predicate device, as claimed in the conclusion.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in K131115) |
|---|---|
| Performance equivalent to predicate device (K100195) in a clinical environment | "This submission provides test results in clinical environment to demonstrate the device is substantial equivalent to the predicate device." |
| Safety equivalent to predicate device (K100195) | "ZeroWire device demonstrates performance, safety, and effectiveness that is equivalent to the predicate device - original ZeroWire submission K100195." |
| Effectiveness equivalent to predicate device (K100195) | "ZeroWire device demonstrates performance, safety, and effectiveness that is equivalent to the predicate device - original ZeroWire submission K100195." |
| Functionality of increased channels (3 to 9) | "The device software (firmware) was modified to increase from 3 channels to 9 channels..." followed by the statement of equivalent performance, safety, and effectiveness. |
| Resistance to interference from other devices | "By utilizing the reserved UWB frequency spectrum, ZeroWire provides a wireless video link that is resistant to interference from other devices." |
| Provision of medical grade quality of service and suitability for surgical environment video transmission challenges | "ZeroWire technology provides the medical grade quality of service and is specifically designed for the video transmission challenges of the surgical environment." |
| Quick and easy installation leveraging proprietary memory-enabled pairing system | "The proprietary memory-enabled pairing system makes installation quick and easy." |
| Enhanced clinical efficiency and safety in the OR by eliminating video cables | "It enhances clinical efficiency and safety in the OR by eliminating the need for a video cable." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "test results in clinical environment." It simply states that such results were provided.
- Data Provenance: The document does not specify the country of origin. It does state that the test results were collected in a "clinical environment," implying a prospective or retrospective observational study or testing directly within a clinical setting. Given the context of showing equivalence for a firmware update, a prospective testing phase in a clinical environment is more likely.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document.
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device for a firmware update to a wireless video transfer system, not on assessing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device is a "wireless video transfer system." Its performance is inherently about the quality and reliability of video transmission, not an AI algorithm performing a diagnostic task. The "test results in clinical environment" would assess the device's ability to transmit video without degradation or interference, which is a standalone performance assessment of the device's hardware and firmware. Therefore, implicitly, yes, a standalone performance assessment of the wireless video transfer capabilities was done.
7. The Type of Ground Truth Used
- For a wireless video transfer system, the "ground truth" would likely involve objective measures of video quality, signal integrity, latency, and reliability of the wireless link, assessed against a "gold standard" or expected performance during endoscopic and general surgical procedures. While not explicitly defined as "ground truth" in the diagnostic sense, the clinical environment test results would have compared the device's video output/performance against a known good reference or accepted clinical standard. It is not expert consensus, pathology, or outcomes data in the typical sense; rather, it relates to the technical fidelity of video transmission during surgical procedures.
8. The Sample Size for the Training Set
- The document is about a firmware modification for an existing device. It does not mention any machine learning or AI components that would require a "training set" in the traditional sense of AI algorithm development. Therefore, the concept of a training set sample size is not applicable here.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable, this information is not provided.
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510(K) SUMMARY
JUN 7 2013
| A. Manufacturer: | NDS Surgical Imaging, LLC5750 Hellyer AvenueSan Jose, CA 95138USA |
|---|---|
| B. Submitted By: | Jim LengRegulatory Engineer/NDS Surgical Imaging, LLC |
| Bl. Address: | NDS Surgical Imaging, LLC5750 Hellyer AvenueSan Jose, CA 95138USA |
| C. Date of Preparation: | April 17, 2013 |
| D. Contact Information: | 408-776-0085Tel:Fax:408-776-9878 |
| E. Classification: | Endoscope and Accessories |
| F. Common Name: | UWB Wireless Device |
| G. Proprietary Name: | ZeroWire Duo Wireless HD Video Transfer System |
| H. Classification number: | 21 CFR 876.1500 |
| IProduct Code: | GCJ |
| J. Substantial Equivalence: | Predicate K100195 ZeroWire Duo Wireless HD VideoTransfer System. |
| K. Device Description: | Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3;x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire wireless deviceis designed as a wireless transmitter and receiver pairwhich allows delivery of a video signal over a radiofrequency link to video destination such as Radiance andEndo Vue devices. The device can operate on up to 9channels. |
| L. Indications for Use: | The NDSsi ZeroWire Duo Wireless HD Video TransferSystem is a paired transmitter and receiver, intended fordelivery of video signals over a radio-frequency link to avideo display during endoscopic and general surgical |
.
RADIANCE DOM
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procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
ZeroWire Duo wireless devices are an advance medical M. Technological Characteristics: grade wireless video transfer solution for minimally invasive surgery and interventional procedures. By utilizing the reserved UWB frequency spectrum, ZeroWire provides a wireless video link that is resistant to interference from other devices. It enhances clinical efficiency and safety in the OR by eliminating the need for a video cable. The proprietary memory-enabled pairing system makes installation quick and easy. ZeroWire technology provides the medical grade quality of service and is specifically designed for the video transmission challenges of the surgical environment.
Clinical data is not needed for this type of wireless device N. Clinical information: by 510(k) submission guidance document. However, this submission provides test results in clinical environment to demonstrate the device is substantial equivalent to the predicate device.
The device software (firmware) was modified to increase from 3 channels to 9 channels, and there is no hardware change. Based upon validations results from both design and clinical, ZeroWire device demonstrates performance, safety, and effectiveness that is equivalent to the predicate device - original ZeroWire submission K100195.
O. Conclusion:
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
NDS Surgical Imaging, LLC % Mr. Jim Leng Regulatory Engineer 5750 Hellver Avenue San Jose, California 95138
Re: K131115
Trade/Device Name: ZeroWire Duo Wireless HD Video Transfer System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 15, 2013 Received: May 20, 2013
Dear Mr. Leng:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jim Leng
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum. 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/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 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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (K131115): K131115
Device Name: ZeroWire Duo Wireless HD Video Transfer System
Indications For Use:
The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a nonsterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogder 2013.06.071 9:07 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510 (k) Number K131115
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.