(56 days)
No
The summary describes standard image processing for display and control, but there is no mention of AI, ML, or any related concepts like pattern recognition, automated analysis, or decision support based on image data. The performance studies focus on safety, biocompatibility, and functional equivalence, not on the performance of any AI/ML algorithm.
No
The device is described as being used in "diagnostic and therapeutic for endoscopic surgery" to establish a path of entry for instruments and provide an image of the surgical field. However, its primary function, as detailed in the "Device Description," is for providing access and visualization, not for directly performing therapeutic interventions. The "therapeutic" aspect in its intended use refers to its role in therapeutic surgery, not as a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" states, "The VisionPort System is intended to be used in diagnostic and therapeutic for endoscopic surgery...to provide an image of the surgical field." This indicates its role in diagnosis through imaging.
No
The device description explicitly lists multiple hardware components including a handpiece with an integrated camera and light source, an access port, a control pad, and a control unit. While it includes image processing software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and therapeutic for endoscopic surgery within the thoracic and peritoneal cavities... to establish a path of entry for endoscopic instruments and to provide an image of the surgical field." This describes a surgical tool used during a procedure to visualize the surgical site and provide access for other instruments.
- Device Description: The components are an access port, camera, light source, control pad, and control unit. These are all components of a surgical visualization and access system.
- No mention of analyzing biological samples: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological samples in this way. It provides a visual image of the internal anatomy.
The "diagnostic" aspect in the intended use refers to the ability to visualize the internal anatomy during the surgical procedure, which aids the surgeon in making decisions and performing the surgery. It does not refer to the analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The VisionPort System is intended to be used in diagnostic and therapeutic procedures for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs to establish a path of entry for endoscopic instruments and to provide an image of the surgical field. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes
GCJ, HET
Device Description
The VisionPort System consists of an access port with an integrated camera and light source, the handpiece, a wired control pad to control the camera functions, and a control unit, specifically:
- VisionPort System Handpiece single use
a. HD camera and lighting module
b. 12.9mm internal diameter access port with 5-12mm instrument seal
c. Lens cleaning system (saline wash and wiper blade)
d. Connections for saline wash source and insufflation tubing
e. Removable obturator designed for visible entry - VisionPort System Control Pad single use
a. Camera control functions (zoom, pan)
b. Light emitting diode (LED) adjustment
c. Image capture and display control buttons - VisionPort System Control Unit
a. System power
b. Image processing (no patient data recording or retention)
c. Outputs to operating room monitor(s) and/or third-party Data Control Unit (for image capture and printing options)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and peritoneal cavities including the female reproductive organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
User: Healthcare Professional
Where Used: Hospital, Surgery Center
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
Not Found
Summary of Performance Studies
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
Sterilization validation was performed as described in ISO 11135:2014. Testing of EtO residuals was conducted per ISO 10993-7. Testing of package seal strength was performed in accordance with ASTM F88. Shelf life confirmed by age testing (accelerated and real time) per ASTM 1980-02.
Biocompatibility testing complied with ISO 10993-1:2009. The battery of tests included: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Pyrogenicity.
Electrical safety and electromagnetic compatibility (EMC) testing complied with IEC 60601-1, IEC 60601-1-6, IEC 62366-1, IEC 60601-2-18, and IEC 60601-1-2.
Functional Testing was performed on the VisionPort Handpiece per ISO 8600-1 through ISO 8600-6 and in accordance with design input requirements. Testing demonstrated that the VisionPort System functions as intended.
Testing was provided which compared performance of the VisionPort System compared to the secondary predicate device (ENDOPATH® XCEL® Bladeless Trocar with OPTIVIEW Technology (K122511)) and to document substantial equivalence in performance related to recommended use. The testing showed that the VisionPort System can be operated in simulated use conditions when used in accordance with the Manual and IFU and is equivalent to the predicate systems for the attributes tested in this protocol.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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June 21, 2021
New View Surgical, Inc. % Maureen O'Connell President O'Connell Regulatory Consultant, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K211250
Trade/Device Name: VisionPort System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, HET Dated: April 23, 2021 Received: April 26, 2021
Dear Maureen O'Connell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name VisionPort™ System
Indications for Use (Describe)
The VisionPort System is intended to be used in diagnostic and therapeutic for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs to establish a path of entry for endoscopic instruments and to provide an image of the surgical field. The trocar may be used with or without visualization for primary and secondary insertions.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
(K211250)
New View Surgical, Inc. VisionPort System
SUBMITTER
New View Surgical, Inc. 555 Massachusetts Ave. Ste. 5 Boston, MA 02118
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: 978-207-1245
Date Prepared: June 2, 2021
DEVICE
Trade Name of Device: VisionPort System Common or Usual Name: Laparoscope Classification Name(s): Laparoscope, General & Plastic Surgery; 21 C.F.R. §876.1500 and Laparoscope, Gynecologic (and Accessories); 21 C.F.R. §884.1720 Regulatory Class: II Product Code(s): GCJ and HET
PREDICATE DEVICE(S)
Primary: Xenocor Xenoscope Laparoscopic System cleared in K161838 ENDOPATH XCEL Bladeless Trocar cleared in K122511 Secondary:
DEVICE DESCRIPTION
The VisionPort System consists of an access port with an integrated camera and light source, the handpiece, a wired control pad to control the camera functions, and a control unit, specifically:
-
- VisionPort System Handpiece single use
- HD camera and lighting module a.
- b. 12.9mm internal diameter access port with 5-12mm instrument seal
- Lens cleaning system (saline wash and wiper blade) C.
- d. Connections for saline wash source and insufflation tubing
- e. Removable obturator designed for visible entry
-
- VisionPort System Control Pad single use
- a. Camera control functions (zoom, pan)
4
- b. Light emitting diode (LED) adjustment
- c. Image capture and display control buttons
-
- VisionPort System Control Unit
- a. System power
- b. Image processing (no patient data recording or retention)
- Outputs to operating room monitor(s) and/or third-party Data Control Unit (for image C. capture and printing options)
INDICATIONS FOR USE
The VisionPort System is intended to be used in diagnostic and therapeutic procedures for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs to establish a path of entry for endoscopic instruments and to provide an image of the surgical field. The trocar may be used with or without visualization for primary and secondary insertions.
SUBSTANTIAL EQUIVALENCE
The VisionPort System described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device. The VisionPort System is substantially equivalent to the Xenosope Laparoscopic System cleared in K161838 and a secondary predicate device, the ENDOPATH XCEL Bladeless Trocar cleared in K122511. A comparison to the primary predicate device is provided in Table 1 and to the secondary predicate device in Table 2. The combined intended use of the primary predicate and secondary predicate is the same as the intended use of the VisionPort System.
| VisionPort System Substantial Equivalence: Primary Predicate Device | ||
|---|---|---|
| Characteristic | VisionPort System | Xenocor Xenoscope |
| Laparoscopic System | ||
| 510(k) Number | K211250 | K161838/K171344 |
| Product Code | GCJ, HET | GCJ, HET |
| Indications for Use | Intended to be used in | |
| diagnostic and therapeutic | ||
| procedures for endoscopic | ||
| surgery within the thoracic | ||
| and peritoneal cavities | ||
| including the female | ||
| reproductive organs to | ||
| establish a path of entry for | ||
| endoscopic instruments and | ||
| to provide an image of the | ||
| surgical field. The trocar may | ||
| be used with or without | ||
| visualization for primary and | ||
| secondary insertions. | Intended to be used in diagnostic | |
| and therapeutic procedures for | ||
| endoscopy and endoscopic | ||
| surgery within the thoracic and | ||
| peritoneal cavities including the | ||
| female reproductive organs. | ||
| Clearance Type | Prescription | Prescription |
| User | Healthcare Professional | Healthcare Professional |
| Where Used | Hospital, Surgery Center | Hospital, Surgery Center |
| System Description | The system includes the following components: | |
| -VisionPort System | ||
| Handpiece | ||
| -VisionPort System Control Pad | ||
| -VisionPort System Control Unit | The system includes the following components: | |
| -Xenoscope Laparoscope Device | ||
| -Xenoscope Dongle | ||
| Component | ||
| Comparison | VisionPort System | |
| Handpiece | Xenoscope Laparoscope | |
| Image Sensor | CMOS | CMOS |
| Lens | 0° | 0° |
| LEDs | 2 | 1 |
| Video Image | High-definition video | High-definition video |
| Image Transfer | Video cable from camera/scope to Control Unit | Video cable from camera/scope to Control Unit (Dongle) |
| Placement into | ||
| Body Cavity | Incorporates an access port/trocar | Inserted through an access port/trocar |
| Lens Cleaning | Incorporates a lens cleaning system (saline flush and wiper) | No lens cleaning system |
| Camera Focus | Fixed Focus | Manual Focus |
| Camera Zoom | Electronic Zoom | Manual Zoom |
| Camera Light | Light (LED) Attenuation | Light (LED) Attenuation |
| Camera Monitor | Monitor Display Control | Monitor Display Control |
| Camera Image | ||
| Capture Relay | Image Capture Relay using third party image capture system | NA |
| Sterility | Single use sterile | Single use sterile |
| Component | ||
| Comparison | VisionPort System Control Unit | Xenoscope Dongle |
| Use | Multi-use | Multi-use |
| Image Transfer | ||
| from | ||
| Camera/Scope to | ||
| Control Unit | Video Cable | Micro-HDMI |
| Image Transfer | ||
| from Control Unit | ||
| to Monitor | DVI | HDMI v1.3 |
| USB | 2.0 service port (manufacturing) | 3.0 service port (manufacturing) |
| Standards | ||
| Compliance | ||
| Electrical Safety | Per IEC 60601-1 | Per IEC 60601-1 |
| EMC | Per IEC 60601-1-2 | Per IEC 60601-1-2 |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 |
Table 1 VisionPort System Sub ce
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| Characteristic | VisionPort System | ENDOPATH XCEL Bladeless
Trocar with OPTIVIEW
Technology |
|----------------|-------------------|---------------------------------------------------------------|
| 510(k) Number | K211250 | K122511 |
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| Product Code | GCJ, HET | GCJ |
|---|---|---|
| Indications for | ||
| Use | Intended to be used in | |
| diagnostic and therapeutic | ||
| procedures for endoscopic | ||
| surgery within the thoracic and | ||
| peritoneal cavities including the | ||
| female reproductive organs to | ||
| establish a path of entry for | ||
| endoscopic instruments and to | ||
| provide an image of the | ||
| surgical field. The trocar may | ||
| be used with or without | ||
| visualization for primary and | ||
| secondary insertions. | Has applications in abdominal, | |
| thoracic, and gynecological | ||
| minimally invasive surgical | ||
| procedures to establish a path of | ||
| entry for endoscopic instruments. | ||
| The trocar may be used with or | ||
| without visualization for primary | ||
| and secondary insertions. | ||
| Clearance Type | Prescription | Prescription |
| User | Healthcare Professional | Healthcare Professional |
| Where Used | Hospital, Surgery Center | Hospital, Surgery Center |
| Components | Sleeve and obturator | Sleeve and obturator |
| Cannula Length | 100 mm | 100 mm |
| Cannula Inner | ||
| Diameter | 12.9 mm | 12.9 mm |
| Cannula Outer | ||
| Diameter | 17.8 mm | 15.5 mm |
| Endoscopic View | Incorporates a 0-degree | |
| endoscopic view of the trocar | ||
| tip and provides visibility of | ||
| individual tissue layers during | ||
| insertion using an image | ||
| capture chip, light source and | ||
| mirror | Accommodates a 0-degree or 30- | |
| degree endoscope to view the | ||
| trocar tip and provides visibility | ||
| of individual tissue layers during | ||
| insertion. | ||
| Seal System | The sleeve has a two-seal | |
| system for maintaining | ||
| pneumoperitoneum. The trocar | ||
| sleeves contain two seals, an | ||
| outer integrated non-removable | ||
| self-adjusting seal that | ||
| accommodates instruments | ||
| ranging from 5 to 12 mm in | ||
| diameter and an internal seal. | The sleeve has an integrated two- | |
| seal system for maintaining | ||
| pneumoperitoneum. The trocar | ||
| sleeves contain two seals, an | ||
| outer integrated removable self- | ||
| adjusting seal that accommodates | ||
| instruments ranging from 5 to 12 | ||
| mm in diameter and an internal | ||
| seal. | ||
| Stopcocks | The sleeve has two welded | |
| stopcocks on the side of the | ||
| cannula assembly, both | ||
| compatible with standard luer | ||
| lock fittings which provide for | ||
| attachment of insufflation | ||
| tubing and a saline flush for | ||
| lens cleaning. | The sleeve has one welded | |
| stopcock assembly, which is | ||
| compatible with a standard luer | ||
| lock fitting which provides for | ||
| attachment of insufflation tubing. | ||
| Stability Threads | Sleeve cannula contains | |
| integrated stability threads for | Sleeve cannula contains | |
| integrated stability threads for |
The VisionPort System has the same technological characteristics as the combination of the primary and secondary predicate devices. The different technological characteristics of the
7
devices do not raise different questions of safety and effectiveness. Performance data is provided which supports substantial equivalence.
PERFORMANCE DATA
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
Sterilization and Shelf Life
Sterilization validation was performed as described in ISO 11135:2014, Sterilization of healthcare products -Ethylene oxide - Requirements for the development. validation and routine control of a sterilization process for medical devices. The sterilization assurance level (SAL) is 10-6.
Testing of EtO residuals was conducted per ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. VisionPort System Handpiece samples met the requirements of the standard.
Testing of package seal strength was performed in accordance with ASTM F88 - Standard Test Method for Seal Strength of Flexible Barrier Materials. All samples demonstrated a seal strength greater than 1.0 lbf/in specification. Visual inspection shows that all seals met specifications with no anomalies noted. The shelf life is confirmed by age testing both accelerated and real time in accordance with ASTM 1980-02. Reference Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
Biocompatibility Testing
The materials used for the VisionPort System comply with biocompatibility requirements outlined in ISO 10993-1:2009 and the Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process and are considered to be biocompatible. The contact type of the VisionPort System is: external communicating, tissue contact with limited contact duration and testing was provided to show compliance with ISO 10993-1. The battery of tests included:
- . Cytotoxicity
- . Sensitization
- Intracutaneous Irritation
- Systemic Toxicity ●
- . Pyrogenicity
Electrical safety and electromagnetic compatibility (EMC)
The VisionPort System was tested for electrical safety and found to be in compliance with IEC 60601-1. IEC 60601-1-6. IEC 62366-1 and IEC 60601-2-18, and for electromagnetic compatibility to IEC 60601-1-2.
Functional Testing
Testing was performed to verify that the VisionPort Handpiece functions as intended:
8
- When tested in accordance with ISO 8600-1 through ISO 8600-6. All test results met . acceptance criteria and were performed in accordance ISO 8600.
- In accordance with design input requirements. The test data demonstrates that the ● VisionPort System functions as intended and in accordance with design input requirements.
Testing was provided which compared performance of the VisionPort System compared to the secondary predicate device (ENDOPATH® XCEL® Bladeless Trocar with OPTIVIEW Technology (K122511)) and to document substantial equivalence in performance related to recommended use. The testing showed that the VisionPort System can be operated in simulated use conditions when used in accordance with the Manual and IFU and is equivalent to the predicate systems for the attributes tested in this protocol.
CONCLUSIONS
The performance data supports the safety of the device and shows that the device performs as intended. The substantial equivalence discussion supports the finding of substantial equivalence to the predicate devices.