The SurroundScope System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including the female reproductive organs.

Device Description

The SurroundScope System (SS) is an endoscopic platform for visualization during surgery. The SS System is a modification of the previously cleared WV1 Endoscope (K190190) developed by 270Surgical. The SS System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment. The SS System features two viewing capabilities: standard and extended. The standard view uses one lens and displays a 90 degree field of view while the extended view uses two additional lenses on the side of the tip and displays a 270 degree field of view. Each lens has its own set of LEDs for illumination.

The SS System is comprised of two main components:

SS endoscope (Video endoscope)
Camera Controller Unit (CCU) (Video Processor)

The SS endoscope is a reusable, rigid video endoscope. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The SS endoscope main components are the video and illumination system, the endoscope body, and the endoscope main connector. The endoscope consists of a camera head at the distal tip, insertion tube, control handle, umbilical cable, and main connector. The insertion tube and distal tip are made of gold coated stainless steel. The distal tip contains sapphire for the optical components. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects the video signal produced by the image sensors (CMOS).

The SurroundScope Camera Control Unit (CCU) processes and manages the images/video signal from the endoscope and transfers them to the monitor. The CCU video center also powers and controls the CMOS located in the SS endoscope.

AI/ML Overview

The SurroundScope System is a rigid video endoscope designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. It supports both standard (90-degree field of view) and extended (270-degree field of view) viewing capabilities. The system comprises an SS endoscope (reusable, rigid video endoscope) and a Camera Controller Unit (CCU).

Here's an analysis of the acceptance criteria and the studies performed to demonstrate the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated format. However, it states that "All tests met the predefined acceptance criteria" for various bench tests. The performance data section describes the tests performed and their successful outcomes. For the purpose of this response, I will synthesize the information regarding "acceptance criteria" from the fact that studies were conducted to industry standards and FDA guidance, and "reported device performance" from the statement that the devices met these criteria.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Safety & Biocompatibility	Cleaning and Sterilization (AAMI TIR12, TIR30, ISO 17665-1, FDA Guidance)	Device successfully passed cleaning, drying, and sterilizations according to instructions. Optical resolution maintained after multiple reprocessing cycles.
	Biocompatibility (ISO 10993-1, -5, -10, -11, USP <151>)	All tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity) demonstrated the device is biocompatible for its intended use.
	Electrical Safety (IEC 60601-1, IEC 60601-2-18)	Demonstrated electrical safety.
	Electromagnetic Compatibility (IEC 60601-1-2)	Demonstrated electromagnetic compatibility.
	Photobiological Safety (IEC 62471)	Demonstrated photobiological safety.
Performance	Optical Performance (ISO 8600-1, -3, -5)	Verified field of view, depth of field, direction of view, signal-noise ratio, non-uniformity, and distortion. Optical comparative testing to predicate demonstrated equivalent optical performance.
	Color Accuracy (CIE ISO standards)	Color testing conducted according to multiple CIE ISO standards for colorimetry and color management. (Implied successful completion as explicitly stated "All tests met the predefined acceptance criteria.")
	System Functionality & Latency	Overall system tested for general functionality and latency. (Implied successful completion.)
	Dimensional Testing (ISO 8600-1)	Dimensional specifications tested and met.
Software	Software Validation (FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices")	Software validated based on a moderate level of concern. (Implied successful completion.)

2. Sample Size for the Test Set and Data Provenance

The document describes various bench tests, but it does not specify the sample sizes used for these tests. For cleaning, drying, and sterilization, it mentions "multiple reprocessing cycles." For biocompatibility, it refers to standard ISO test methods, which have their own sample size requirements, but these are not enumerated here.

The data provenance is from bench testing and conducted by an independent lab (Wuxi AppTec) for specified tests (cleaning, drying, sterilization). There is no indication of human subject data, country of origin is not specified for the test set, and it is entirely retrospective as it's a pre-market submission for a device.

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

Since the studies described are primarily bench testing (physical, electrical, optical, and chemical properties, as well as software validation), the concept of "ground truth" derived from human experts in a clinical context (e.g., radiologists, pathologists) does not directly apply here.

The "ground truth" for these performance tests is established by the relevant industry standards (ISO, IEC, AAMI, USP) and FDA guidance documents, which define the expected performance metrics and acceptable thresholds. The "experts" involved would be the testing engineers and scientists at the independent labs or internally, who are qualified to conduct these specific technical tests according to the standards. No specific number or qualifications of these technical experts are provided in the document.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective, quantitative bench tests against established engineering and scientific standards, not subjective interpretations requiring adjudication by human experts.

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 through bench testing, safety, and performance against a predicate device and established standards. This type of study would typically be performed for AI-driven diagnostic or interpretative devices to assess human performance with and without AI assistance, which is outside the scope of this endoscope system's pre-market submission description.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, standalone performance (in the context of a medical device's technical capabilities without human interaction) was assessed for various parameters of the SurroundScope System. For example:

Optical Performance: Field of view, depth of field, signal-noise ratio, non-uniformity, distortion were measured objectively.
Color Accuracy: Tested against colorimetry standards.
System Functionality and Latency: Assessed as objective system performance.
Electrical Safety and Electromagnetic Compatibility: Tested to ensure compliance with standards regardless of human interaction during use.
Software Validation: The software itself was validated.

These are all measures of the device's inherent technical performance without considering how a human user might interact with or interpret the output in a clinical scenario.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

Industry and International Standards: Such as ISO 8600 series for endoscopes, IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, AAMI TIRs for reprocessing, and various CIE ISO standards for colorimetry. These standards define the acceptable range and methodology for measuring performance.
FDA Guidance Documents: For reprocessing and software validation, these documents outline the expected validation methods and content for pre-market submissions.
Specifications: Predefined acceptance criteria for the device itself, derived from these standards and the manufacturer's own design specifications (e.g., 90°/270° field of view, 17-200mm depth of field).

8. The Sample Size for the Training Set

Not applicable. The SurroundScope System is a hardware endoscope with integrated software for image processing and control. It is not an AI/ML device that requires a "training set" of data in the sense of machine learning. The term "software validation" refers to verifying that the software performs its intended functions correctly and reliably, not to training an algorithm.

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

Not applicable, as there is no "training set" for this device. The software validation is based on requirements and specifications defined by the developer and adherence to FDA guidance.

Summary

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July 8. 2021

270Surgical Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103

Re: K210104

Trade/Device Name: SurroundScope System Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, GCJ Dated: June 8, 2021 Received: June 8, 2021

Dear Janice M. Hogan:

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/cdrh/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.

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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,

for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K210104

Device Name SurroundScope System

Indications for Use (Describe)

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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K210104 510(k) Summary 270Surgical Ltd.'s SurroundScope System

1. Submitter's Identification

270Surgical Ltd. P.O.B 8414, 4 Arie Regev St. Netanya, Israel, 4250212 Phone: +972-509911918 Contact Person: Meital Yogev

Date Prepared: July 6, 2021

2. Name of Device

Name of Device: SurroundScope System Common or Usual Name: Gynecologic Laparoscope and Accessories Requlation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET (Laparoscope, Gynecologic (And Accessories)) Additional Product Code: GCJ (Laparoscope, General & Plastic surgery)

3. Predicate and Reference Device Information

Predicate: K190190, 270Surgical, WV1 Endoscope Reference: K151011, Olympus Medical Systems Corp., VISERA 4K UHD SYSTEM Endoscopic Imaging System.

The predicate device has not been subject to a design-related recall.

4. Device Description

The SS System is comprised of two main components:

SS endoscope (Video endoscope) ●
Camera Controller Unit (CCU) (Video Processor)

SS Endoscope:

The SS endoscope is a reusable, rigid video endoscope.

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It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as to reprocess the device after each use.

The SS endoscope main components are the video and illumination system, the endoscope body, and the endoscope main connector. The endoscope consists of a camera head at the distal tip, insertion tube, control handle, umbilical cable, and main connector. The insertion tube and distal tip are made of gold coated stainless steel. The distal tip contains sapphire for the optical components. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects the video signal produced by the image sensors (CMOS).

SS System Video Center (CCU)

5. Indications for Use

The subject device SurroundScope and predicate device K190190 have similar intended use and indications for use (IFU) as follows:

SurroundScope System (K210104) IFU statement:

"The SurroundScope System is designed to be used with documentation equipment, monitor. hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

WV1 Endoscope (K190190) IFU statement:

"The WV1 endoscope is a reusable, rigid, video endoscope, designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs."

Both the subject device and predicate device are intended for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. Both systems also support the use of documentation equipment, hand instruments, electrosurgical unit, and other ancillary equipment during the same procedures.

Both the subject and predicate devices include an endoscope as their main component. The subject device includes a system comprised of the endoscope and the CCU video system, as in the reference device VISERA 4K UHD SYSTEM cleared under K151011, which was cleared with an endoscope and a video processor unit. This difference does not represent a new intended use or indications for use.

6. Summary of Technological Characteristics and Comparison

The clinical set-up, mode of operation, ergonomics and dimensions of the subject device are similar to the predicate device, 270Surgical's WV1 Endoscope (K190190). Like the subject device, the WV1 Endoscope's main components are the Video endoscope connected to a video processor. The endoscope itself is comprised of the video system, the endoscope body. and the endoscope main connector. In both devices, the required illumination for the endoscope is located on the endoscope's distal tip, and the video signal is produced by the image sensors. The video signal in the subject device is produced by CMOS (Complementary

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Metal Oxide Semiconductor) image sensors, while the predicate device's distal tip is equipped with a color CCD (Charge Couple Device).

The primary difference between the subject and predicate device is the output resolution, depth of field, image sensor type, and the video system. These differences in technological characteristics do not raise different questions of safety and effectiveness. A substantial equivalence table, which summarizes the similarities and differences between the SS System and its predicate device, is included below (Table VI-1).

Parameter	K210104 - 270SurgicalSurroundScope System[Proposed Device]	K190190 - 270Surgical WV1Endoscope[Predicate]
Indication forUse	The SurroundScope System isdesigned to be used withdocumentation equipment,monitor, hand instruments,electrosurgical unit, and otherancillary equipment forendoscopy and endoscopicsurgery within the thoracic andabdominal cavities, including thefemale reproductive organs.	The WV1 endoscope is a reusable,rigid, video endoscope, designed tobe used with a video system center,light source, documentationequipment, monitor, handinstruments, electrosurgical unit, andother ancillary equipment forendoscopy and endoscopic surgerywithin the thoracic and abdominalcavities including the femalereproductive organs.
Class	II	II
Regulation	21 CFR§ 884.1720	21 CFR§ 884.1720
Code	HET	HET
Additionalproduct code	GCJ per 21 CFR §876.1500	GCJ per 21 CFR §876.1500
Method ofOperation	The optical image is transferred from the surgical site to the camerahead.
ImagingSystem	Electronic
Field of View	90° ± 10°/ 270° ± 10°
Depth of Field(DOF), Front	17-200 mm	12-175 mm
Direction ofview	0°, 90°, -90°	0°, 90°, -90°
Articulation	No	No
Irrigation	No	No
Illumination	Integrated LED
Illuminationfibres	No	No
Coupling Lens	No	No
Diameter	10 mm	10 mm
Working length		340 mm
Parameter	K210104 - 270SurgicalSurroundScope System[Proposed Device]	K190190 - 270Surgical WV1Endoscope[Predicate]
Eyepiece	No	No
Optical System	Color
No. of Image sensors	3 sensors
Output resolution	4K (2160p) and HD (1080p)	HD (1080p)
Sterilization	Autoclave
Control Handle		Buttons on handle
Video System	CCU by 270Surgical	Fuse Box Processor (K13289)
Max power	400 VA max	250 VA max
Digital video outputs (display)	3 x 3G SDI (1080p)1 x 12G SDI (2160p)	3 x DVI (1080p)
Video processor Weight	4.5 [kg]	9.5 [kg]
Video processor Dimensions	318 x 93 x 450 [mm]	380 x 450 x 170 [mm]
Operating Ambient temperature	5 to 35 °C ( 41 to 95 °F)	10 to 35 °C ( 50 to 95 °F)
Operating Relative humidity	30 to 85 % Atmospheric
Operating Atmospheric pressure	700 to 1060 hPa
Storage Temperature	-30 to 60 °C ( -22 to 140 °F)	10 to 40 °C ( 50 to 104 °F)
Storage Relative humidity	30 to 75 %
Transport Temperature	-47 to 70 °C (-52 to 158 °F)
Transport Relative humidity	10 to 95 %
Electric Shock Protection	BF

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Table VI-1: Comparison Table

7. Summary of Performance Data

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Bench testing was performed per the following voluntary performance standards or FDA guidance:

Sterilization, Cleaning: Cleaning, drying and sterilizations were conducted for the SS System, according to AAMI TIR12: 2010. AAMI TIR30: 2011/(R)2016, and ISO 17665-1: 2006. Reprocessing validation was carried out in accordance with the FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff (March 17, 2015). The studies were performed by an independent lab, Wuxi AppTec. These tests demonstrated that the device successfully passed cleaning, drying and sterilizations according to the instructions in the product Reprocessing Manual. The optical resolution was also evaluated after multiple reprocessing cycles to demonstrate the specifications were still met after reprocessing.

Biocompatibility Testing: Biocompatibility testing was performed in accordance with the FDA Guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process" (September 4, 2020) for an external communicating device in contact with tissue for a limited duration, as follows:

i. Cytotoxicity (ISO 10993-5:2009)
ii. Sensitization (ISO 10993-10:2010)
iii. Irritation (ISO 10993-10:2010)
iv. Acute Systemic Toxicity (ISO 10993-11: 2017)
v. Material-Mediated Pyrogenicity (USP <151>)

All tests demonstrated that the device is biocompatible for its intended use.

Electrical Safety and Electromagnetic Compatibility: testing were conducted according to IEC 60601-1:2005/(R)2012 and A1:2012, (3rd Ed. + AM1), IEC 60601-1-2: 2014, 4th Edition, and IEC 60601-2-18:2009 (Third Edition) that demonstrated electrical safety and electromagnetic compatibility of the subject device.

Software validation: The subject device software was validated per the FDA quidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) based on a moderate level of concern.

Bench Testing:

. Optical Performance: Optical testing was done to verify field of view, depth of field, direction of view, signal-noise ratio, non-uniformity, and distortion, according to ISO 8600-1: 2015, ISO 8600-3: 2019; and ISO 8600-5: 2005. Optical comparative testing to the predicate device was done using the same methods to demonstrate equivalent optical performance.
Photobiological Safety: Testing was conducted according to IEC 62471;2006 that ● demonstrated photobiological safety for the subject device.
Color accuracy: Color testing was done according to the following standards: ●
- CIE ISO 11664-1:2019 Colorimetry Part 1: CIE standard colorimetric ● observers
- CIE ISO 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 Colorimetry - Part 2: CIE standard illuminants
- CIE ISO 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
- CIE ISO 11664-4 First edition 2019-06 Colorimetry Part 4: CIE 1976 Lab* ● colour space

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CIE ISO 11664-6 First edition 2014-02-01 Colorimetry Part 6: CIEDE2000 ● colour-difference formula
. CIE ISO 61966-2-1 First edition 1999-10 Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
System testing: The overall system was tested for general functionality and latency ●
Dimensional testing: Dimensional specifications were tested per ISO 8600-1: 2015. .

All tests met the predefined acceptance criteria.

8. Conclusions

The SurroundScope System has the same intended use and similar technological characteristics as the predicate device, WV1 Endoscope. Performance testing, including electrical safety, electromagnetic compatibility, cleaning validation, sterilization validation, biocompatibility, and bench testing has demonstrated that the SurroundScope System is as safe and effective as the predicate device. Therefore, the SurroundScope system is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.