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

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the medical device P-Scope. This document focuses on demonstrating that the P-Scope is "substantially equivalent" to legally marketed predicate devices, primarily through non-clinical testing. It explicitly states that "The subject devices do not require clinical studies to support the determination of substantial equivalence."

Therefore, based solely on the provided text, there is no information available regarding acceptance criteria related to AI performance, sample sizes for test sets (as no clinical test sets were used for AI evaluation), expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details. The 510(k) summary concerns the physical endoscope device and its safety/performance, not an AI component.

To fulfill your request, I must state what can be extracted from the document concerning the device's validation against its intended use, even if it doesn't involve AI.

Here's an interpretation based on the provided text, highlighting the absence of information related to AI-specific criteria, as the document doesn't pertain to an AI device:

Device: P-Scope (Endoscope)
Regulatory Submission: K241502

Based on the provided K241502 510(k) summary, the P-Scope device's acceptance criteria and proven performance relate to its physical and functional attributes as an endoscope, not to an AI component or its performance. The document explicitly states that "The subject devices do not require clinical studies to support the determination of substantial equivalence." Therefore, no information regarding AI-specific acceptance criteria or human-AI interaction studies is present.

The study that proves the device meets the acceptance criteria is detailed as non-clinical bench testing, EMC, and electrical safety testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Related):

Acceptance Criteria Category	Specific Criteria (Implicitly based on standards)	Reported Device Performance (Summary)
Physical Design	- Single-use, sterile laparoscope with camera mounted on 3 or 5 mm rigid shaft	- Device has these physical characteristics
Imaging System	- High-definition video camera	- Integrated
	- LED lighting for illumination	- Used for clear visibility
	- Resolution of 160K pixels (400x400)	- Achieved, noted as lower than predicate but wider FoV
	- 120° Field of View (FoV)	- Achieved
Display Unit	- Reusable high-definition video display	- Integrated
	- USB and HDMI ports	- Functioning for external connections
Sterility	- Provided sterile (typically via EO gas)	- Achieved
Biocompatibility	- Biocompatible as per ISO 10993 standards	- Achieved
Safety (Electrical)	- Conformity to IEC 60601-1-2:2014+A1:2020 (EMC)	- Successfully completed
	- Conformity to IEC/TR 60601-4-2:2016-05 (EMC)	- Successfully completed
	- Conformity to ANSI AAM ES 60601-1:2005+A1:2020 (Electrical safety)	- Successfully completed
	- Conformity to IEC 60601-2-18:2009 (Electrical safety)	- Successfully completed
Performance (Bench)	- Conformity to ISO 8600-1 "Endoscopes — Medical endotherapy devices — Part 1: General requirements"	- Successfully completed

2. Sample Size Used for the Test Set and Data Provenance:

Test Set: No patient or image data test sets were used, as the validation was based on non-clinical bench testing of the physical device.
Data Provenance: Not applicable for a non-clinical, non-AI device validation. The testing was conducted in accordance with international and FDA-recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth in the context of AI/diagnostic accuracy was not established, as no clinical test set was used and there is no AI component. The validation focused on engineering specifications and safety standards met through bench testing.

4. Adjudication Method for the Test Set:

Not applicable. No human-interpreted test sets requiring adjudication were involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not conducted because:
- The device is an endoscope, not an AI image analysis system.
- The submission explicitly states, "The subject devices do not require clinical studies to support the determination of substantial equivalence."

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

Not applicable. There is no algorithm or AI component to report standalone performance for.

7. Type of Ground Truth Used:

Not applicable. For this submission, "ground truth" refers to the engineering specifications and performance benchmarks outlined in the referenced international standards (e.g., ISO 8600-1, IEC 60601 series). The device's performance was measured against these predefined physical and electrical safety parameters.

8. Sample Size for the Training Set:

Not applicable. There is no AI component, and thus no training set was used.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no AI component or training set.

In summary, the provided FDA 510(k) summary for the P-Scope pertains to a conventional medical device (an endoscope) and not an AI-powered device. Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment, and human-AI studies are not addressed by this document. The device's acceptance criteria are met through adherence to established engineering, safety, and performance standards via non-clinical bench testing.

Summary

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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 (1-800-638-2041 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 TX75247 United States
Applicant Contact Telephone	+919972446882
Applicant Contact	Dr. Adarsh M. Patil
Applicant Contact Email	ap@oui-medical.com
Correspondent Name	OUI Medical Inc.
Correspondent Address	3000 PEGASUS PARK DR. SUITE 1330, DALLAS, TX 75247 DallasTX 75247 United States
Correspondent Contact Telephone	+91 9986864176
Correspondent Contact	Mr. Pavan Kumar Palamkota
Correspondent Contact Email	pavan@oui-medical.com
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 #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)

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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)

Regulation Number and Section

§ 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.