P-SCOPE

K241502 · Oui Medical, Inc. · GCJ · Jul 24, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241502
• Device Name: P-SCOPE
• Applicant: Oui Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.

Device Story

P-Scope is a single-use, sterile laparoscope with a 3mm or 5mm rigid shaft and integrated camera; used with a reusable high-definition video display/processor. Device captures surgical field images via LED illumination; transmits video feed to display via USB/HDMI connections. Operated by surgeons in clinical settings for visualization during endoscopic procedures. Provides 120° field of view to assist in anatomical navigation and identification. Benefits include simplified, stable visualization for diagnostic and therapeutic tasks; reduces need for scope repositioning. Output is visual; aids surgeon in real-time clinical decision-making during surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by performance bench testing, including ISO 8600-1, IEC 60601-1-2, IEC/TR 60601-4-2, ANSI AAMI ES 60601-1, and IEC 60601-2-18 standards.

Technological Characteristics

Rigid shaft laparoscope (3mm or 5mm); LED illumination; 120° field of view; 160K pixel resolution (400x400). Biocompatible materials per ISO 10993. Sterilization via EO gas. Connectivity via USB/HDMI to external displays. Class II device, 21 CFR 876.1500.

Indications for Use

Indicated for diagnostic and therapeutic endoscopic procedures within the peritoneal cavities, including female reproductive organs, in patients requiring such interventions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Saberscope5 Laparoscope (K220872)
• VisionPort System (K211250)

Submission Summary (Full Text)

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July 24, 2024

OUI Medical Inc. Pavan Kumar Palamkota Regulatory Consultant 3000 Pegasus Park Dr. Suite 1330 Dallas, Texas 75247

Re: K241502 Trade/Device Name: P-scope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ. GCO Dated: May 28, 2024 Received: May 28, 2024

Dear Pavan Kumar Palamkota:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 [phone] or 301-796-7100).

Sincerely,

Long H. Chen -- S Digitally signed by Long H.Chen-S
Date: 2024.07.24 15:43:48 -04'00'

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 Ouality Center for Devices and Radiological Health

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241502

Device Name

P-SCOPE

Indications for Use (Describe)

P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.

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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| K24150 | | | | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------|-------------------------|--|
| 510(k) Summary | | | Prepared on: 2024-07-24 | |
| Contact Details | | | 21 CFR 807.92(a)(1) | |
| Applicant Name | OUI Medical Inc. | | | |
| Applicant Address | 3000 PEGASUS PARK DR. SUITE 1330, DALLAS, TX 75247 Dallas TX<br>75247 United States | | | |
| Applicant Contact Telephone | [phone] | | | |
| Applicant Contact | Dr. Adarsh M. Patil | | | |
| Applicant Contact Email | [e-mail] | | | |
| Correspondent Name | OUI Medical Inc. | | | |
| Correspondent Address | 3000 PEGASUS PARK DR. SUITE 1330, DALLAS, TX 75247 Dallas<br>TX 75247 United States | | | |
| Correspondent Contact Telephone | [phone] | | | |
| Correspondent Contact | Mr. Pavan Kumar Palamkota | | | |
| Correspondent Contact Email | [e-mail] | | | |
| Device Name | | 21 CFR 807.92(a)(2) | | |
| Device Trade Name | P-Scope | | | |
| Common Name | Endoscope and accessories | | | |
| Classification Name | Laparoscope, General & Plastic Surgery | | | |
| Regulation Number | 876.1500 | | | |
| Product Code(s) | GCJ, GCQ | | | |
| Legally Marketed Predicate Devices | | | 21 CFR 807.92(a)(3) | |
| Predicate #<br>Predicate Trade Name (Primary Predicate is listed first) | | Product Code | | |
| K220872 | Saberscope5 Laparoscope | GCJ | | |
| K211250 | VisionPort System | GCJ | | |
| Device Description Summary | | | 21 CFR 807.92(a)(4) | |

The device contains two separate functioning components. First is the single-use, sterile P-scope device, which includes camera mounted on a 3 or 5 mm rigid shaft and reusable high-definition video display includes ports such as USB and HDMI, which allow for connections to external high-definition video screens. This feature enables the surger and more detailed view of the surgical field during the procedure.

In summary, the P-scope combines the single-use laparoscope device with a high-definition video camera for imaging, and a reusable video display with an image processor for displaying the video feed, along with connectivity options to external video screens.

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# Intended Use/Indications for Use

P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.

# Indications for Use Comparison

The Indications for Use is the same as the predicate device

# Technological Comparison

The P-scope, alongside its predicate devices Saberscope and VisionPort System, shares significant technological similarities that establish a foundation for their use in diagnostic and therapeutic procedures within peritoneal cavities. All three devices are classified under Class II with regulation number 21 CFR 876.1500 and carry the product code GCJ, underscoring their designation as endoscopes and accessories. Their design incorporates a high-definition video imaging system within a laparoscope structure designed for sincle use, leveraging LED lighting for illumination to ensure clear visibility of the surgical field. The devices are provided sterile, typically via EO gas, with materials that are biocompatible as per ISO 10993 standards, supporting their safe intraoperative use..

However, the P-scope and Saberscope diverge significantly in their technological characteristics, notably in terms of articulation capabilities, visualization, and display resolution. The P-scope, with its rigid shaft design, focuses on stability and simplicity, contrasting with the Saberscope's ±90° articulating tip that offers enhanced maneuverability. Additionally, the P-scope differentiates itself by offering a 120° field of view, providing broader visibility than typical endoscopes. This feature, combined with a resolution of 160K piels (400x400), distinguishes the P-scope from the Saberscope, which boasts a higher resolution of 1080p. Despite the lower resolution, the P-scope's wider field of view aims to improve procedural efficiency by reducing the need for scope repositioning and enhancing the surgeon's ability to navigate and identify anatomical structures. Together, these features position in endoscopic device design, prioritizing expansive visualization and streamlined operation while maintaining the critical safety and effectiveness standards established by its predicate devices.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clincal testing was designed and developed in accordance with applicable requirements and stablish performance and safety of the subject device P-SCOPE. These include performance bench testing

ISO 8600-1 "Endoscopes — Medical endotherapy devices — Part 1: General requirements", as well as EMC and Electrical safety in accordance with IEC 60601-1-2:2014+A1:2020,Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA-recognized voluntary consensus standard: 19-36) and IEC/TR 60601-4-2 Edition 1.0 2016-05, Medical Electrical Equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity; performance of medical electrical electrical systems (FDArecognized voluntary consensus standard: 19-19), ANSI AAM ES 60601-1:2005 + A 1:20 2 , Medical Electrical Equipment – Part 1 : General requirements for basic safety and essential performance (FDA-recognized voluntary consensus standard: 19-4),and IEC 60601-2-18:2009, Medical electrical equipment – Part 2-18: Particular requirements for the safety of equipment (FDA-recognized voluntary consensus standard: 9-114). Verification and validation testing successfully completed that the device conform with recognized safety standards, design input specifications, user needs and intended uses.

The subject devices do not require clinical studies to support the determination of substantial equivalence.

The P-SCOPE has the same intended use and indications for use, and fundamental technology as the predicate device. In summary, P-SCOPE is the same or similar with respect to safety and effectiveness to the legally marketed predicate device.

### K241502 R 807.92(a)(5)

## 21 CFR 807.92(a)(6)

## 21 CFR 807.92(a)(5)