(147 days)
Not Found
No
The document mentions "image processing" but does not explicitly mention AI, ML, deep learning, or any related terms. The description of the device's operation principles being similar to standard gastroscopic systems further suggests the absence of novel AI/ML components.
Yes
The intended use explicitly states that the system "provides access for therapeutic interventions using standard endoscopy tools."
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PeerScope System is intended for diagnostic visualization of the digestive tract." Additionally, the "Device Description" section reiterates that it is a "G1 platform for diagnostic visualization and therapeutic intervention of the digestive tract".
No
The device description explicitly states that the system consists of hardware components including camera heads, endoscopes, video system, light source, and a Main Control Unit (MCU) Videoprocessor.
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 visualization of the digestive tract" and "therapeutic interventions". This involves directly viewing the internal anatomy and performing procedures, not analyzing samples taken from the body.
- Device Description: The description focuses on the components of an endoscope system (camera heads, endoscopes, video system, light source, etc.) used for direct visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Product codes (comma separated list FDA assigned to the subject device)
FDS
Device Description
The PeerScope System Model HG is a G1 platform for diagnostic visualization and therapeutic intervention of the digestive tract for use in healthcare facility/hospital. The system consists of the Main Control Unit (MCU) Videoprocessor that provides the device controls, user interfaces, image processing, pneumatic controls and interfaces with various external accessories, and of the PeerScope GS flexible video Gastroscope labeled for repeatable clinical usage within the upper digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard Gastroscopic systems. The system also provides the physicians with two viewing capabilities: Standard 160° front field of view, and 210° wide field of view.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper digestive tract (including the esophagus, stomach, and duodenum)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility/hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench data:
Risk analysis was conducted in accordance with ISO 14971. Design verification tests and their acceptance criteria were identified, preformed and met.
Software validation was carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)".
Reprocessing validation was carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)".
Device safety and performance were verified by EndoChoice Innovation Center Ltd. and accredited third party laboratories.
Usubility Data:
Device Usability was carried out by means of testing within a clinical environment in a US medical center by five experienced GI physicians.
The conclusions drawn from the bench and usability tests demonstrate that the device meets its specifications, and supports a determination that the device is at least as safe and effective for its intended use as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EVIS EXERA II 180 System (K100584), PeerScope System Model H (K130718)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for EndoChoice. The logo consists of a circular swirl design on the left, followed by the word "ENDOCHOICE" in a stylized font. The font appears to be sans-serif and the letters are spaced closely together.
EndoChoice, Inc., 11810 Wills Road Alpharetta, GA 30009
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92
Submitter Details
EndoChoice Inc. 11810 Wills Road OCT 1 0 2013 Alpharetta, GA 30009 Phone: 678-534-6012 866-567-8218 Fax: Date prepared: June 18, 2013 Submission Contact: Tamar Fuerst EndoChoice Innovation Center Ltd. Caesarea, 38900, Israel. Phone: +972-46327731, Fax: +972-46327743
Device Details
Proprietary Name: Classification Name Product Code: Committee/Panel: Device Class:
PeerScope System (Model HG) Endoscope and Accessories, 21 CFR 876.1500 FDS Gastroenterology/Urology II
Reason for 510(k) Submission: New Device
Identification of Legally Marketed Predicates Devices:
EVIS EXERA II 180 System (K100584) by Olympus. PeerScope System Model H (K130718) - by PeerMedical Ltd.
Device Description
The PeerScope System Model HG is a G1 platform for diagnostic visualization and therapeutic intervention of the digestive tract for use in healthcare facility/hospital. The system consists of the Main Control Unit (MCU) Videoprocessor that provides the device controls, user interfaces, image processing, pneumatic controls and interfaces with various external accessories, and of the PeerScope GS flexible video Gastroscope labeled for repeatable clinical usage within the upper digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard Gastroscopic systems. The system also provides the physicians with two viewing capabilities: Standard 160° front field of view, and 210° wide field of view.
PeerScope System Model HG Submission Section 5_ 510(k) Summary
Page I of 4
1
Intended use and indications for Use
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment. ·
Technological characteristics
The PeerScope GS video Gastroscope incorporates the following additional features compared to the predicate device:
| Category | Subject Device:
PeerScope GS
Gastroscope | Predicate Device
Gastrointestinal
Videoscope GIF
Type H180-
(K100584) | Impact of the differences
on device performance |
|-------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Direction of Views | Front and left (side) | Front only | Both designs utilize
standard front view. |
| Standard Field Of
View [degrees] | 160 | 140 | Both designs utilize
industry accepted standard
for Field Of View. |
| Wide Field Of View
[degrees] | 210 | Not included | The Presentation of the
wide view option is a
unique feature of the
PeerScope System feature
of the PeerScope System,
which is not included
EVIS EXERA II 180
System specifications. |
| Depth Of Field [mm] | 3-100 | 2-100 | Both designs utilize
industry accepted standard
for Depth Of Field. |
| Working Length [mm] | 1050 | 1030 | Both designs utilize
industry accepted standard
for Working Length |
| Distal tip Outer
Diameter [mm] | 10.5 | 9.8 | Both designs utilize
industry accepted standard
for Distal tip Outer
Diameter |
| Illumination Type | Integral LED
illumination | Examination lamp | Both systems utilize
accepted industry standard
for illumination |
PeerScope System Model HG Submission Section 5 - 510(k) Summary
Page 2 of 4
2
| Category | Subject Device:
PeerScope GS
Gastroscope | Predicate Device:
Gastrointestinal
Videoscope GIF
Type H180
(K100584) | Impact of the differences
on device performance |
|--------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Narrow band
illumination | Not Included | Included | The narrow band
illumination is a unique
feature of The EVIS
EXERA II 180 System,
which is not included in
the PeerScope System
specifications. |
| Water Flow rate - lens
irrigation | 1.25 cc/sec | 0.9 cc/sec | Both systems utilize
accepted industry standard
for lens irrigation |
| Angulation Range
[degrees] | Up 210, Down 120
Left 120, Right 120 | Up 210, Down 90
Left 100, Right 100 | Both systems utilize
accepted industry standard
for Angulation Range |
Based on the results of verification and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device intended use.
Performance data
Bench data:
Risk analysis was conducted in accordance with ISO 14971. Design verification tests and their acceptance criteria were identified, preformed and met.
Software validation was carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)".
Reprocessing validation was carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)".
Device safety and performance were verified by EndoChoice Innovation Center Ltd. and accredited third party laboratories.
The following standards were used / relied upon for testing:
AAMI / ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2:2007 IEC 60601-2-18 Edition 3.0 2009-08 IEC 62304:2006 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2007 Part #12 ISO 8600-1 Second edition 2005-05-01
PeerScope System Model HG Submission Page 3 of 4 Section 5 - 510(k) Summary
Rev 02
3
ISO 8600-3 First edition 1997-07-01 ISO 8600-4 First edition 1997-07-01 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)
Usubility Data:
Device Usability was carried out by means of testing within a clinical environment in a US medical center by five experienced GI physicians.
The conclusions drawn from the bench and usability tests demonstrate that the device meets its specifications, and supports a determination that the device is at least as safe and effective for its intended use as the predicate device.
Substantial Equivalence
The above presented data demonstrate that:
- The PeerScope System Model HG and the predicate device, EVIS EXERA II 180 હો. System have the same intended use and indications for use in upper digestive tract.
- The PeerScope System Model HG uses the same technologies used by the predicate b. PeerScope System Model H.
- The PeerScope System Model HG does not raise different questions of safety and C. effectiveness.
- The data provided collected by scientific acceptable methods, thus demonstrating d. equivalence and support the indications.
Conclusion: It is the opinion of EndoChoice Innovation Center Ltd. that the PeerScope system Model HG is substantially equivalent to the predicate devices, in terms of safety and effectiveness.
Page 4 of 4
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Giff Silver Spring, MI) 20993-0002
October 10, 2013
EndoChoice, Inc. % Tamar Fuerst RA Manager EndoChoice Innovation Center Ltd. 2 Hatochen Street, Business and Industrial Park (North), POB 3161 Caesarea Israel 38900
Re: K131422
Trade/Device Name: PeerScope System (Model HG) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: 11 Product Code: FDS Dated: August 29, 2013 Received: September 9. 2013
Dear Tamar Fuerst.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
5
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Glenn BiBell -S
Acting for: Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K l 31422
Device Name: PeerScope System (Model HG)
Indications for Use:
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/6/Picture/10 description: The image shows the name "Glenn Bell -S" in a bold, sans-serif font. The letters "enn B" and "Bell" are partially obscured by a decorative design. The design appears to be a stylized emblem or logo, possibly related to the name itself.
PeerScope System Model HG Submission Section 4_Indication for Use Statement
Confidential Page I of I
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