(241 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard endoscopic components and functionality.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system also provides access for therapeutic interventions using standard endoscopy tools."
Yes
The "Intended Use / Indications for Use" section states: "The PeerScope System is intended for diagnostic visualization of the digestive tract." This explicitly indicates its diagnostic purpose.
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).
Based on the provided information, the PeerScope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- PeerScope System Function: The PeerScope System is an endoscopic system used for direct visualization of the digestive tract within the body. It also facilitates therapeutic interventions. It does not analyze specimens taken from the body.
The PeerScope System is a medical device used for in vivo (within the living body) diagnostic visualization and therapeutic procedures.
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 lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.
Product codes
FDF, KOG
Device Description
The PeerScope system consists of endoscopic Main Control Unit (MCU), and of the PeerScope CS colonoscope. The MCU controls the endoscope. As other endoscopic legally marketed systems, it includes video system, light source, and interface to other ancillary equipment. The device labeled for use in healthcare facility/hospital for endoscopy and endoscopic treatment within the lower digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard colonoscopy systems. The PeerScope system model provides 160° standard front field of view and a 300° wide field of view.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve)
Indicated Patient Age Range
adult patients
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
Bench data: The device safety and performance were verified by tests by PeerMedical and accredited third party laboratories. The device performance was validated by testing of a final production unit in simulated clinical conditions focusing on evaluation of the device wide 300° field of view. The procedure was performed by physicians at three US medical centers. Methods and procedures were identical to those used in clinical conditions. The results of the bench validation passed the experiment criteria. The device met its intended use and specifications. Hazardous conditions were not observed.
Clinical Data: The device performance was validated by testing of a final production unit in clinical conditions. The procedure was performed at Elisha Medical Center, Haifa, Israel on a diverse adult population in terms of gender, ethnicity and age. The procedure was performed by US, European and Israeli physicians. Methods and procedures were identical to those used in US-based studies. Fifty (50) patients were enrolled in conformance with the device labeling. The results of the clinical validation passed the experiment criteria. No adverse events were observed.
Key Metrics
Not Found
Predicate Device(s)
ProtectiScope CS -K081004
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.
0
SEP
2 8 2012
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.92)
Submitter Details
PeerMedical Ltd. 2 Hatochen St., PO 3161 Business and Industrial Park (North), Caesarea, 38900, Israel Tel: +972 4 6327731, Fax: +972 4 6327734 Date summary prepared: June 2012 Submission Contact: Dan Laor, 6 Sireni St., Haifa, 32972, Israel.
Device Details
Proprietary Name: Common Name: Classification Name Product Code: Subsequent Product Code: Committee/Panel: Device Class:
PeerScope System Colonoscope and accessories, flexible / rigid Endoscope accessories, 21 CFR 876.1500 FDF KOG Gastroenterology/Urology II
Reason for 510(k) Submission: New Device
Identification of Legally Marketed Predicate Devices
ProtectiScope CS -K081004 - Manufactured by Stryker GI
Device Description
The PeerScope system consists of endoscopic Main Control Unit (MCU), and of the PeerScope CS colonoscope. The MCU controls the endoscope. As other endoscopic legally marketed systems, it includes video system, light source, and interface to other ancillary equipment. The device labeled for use in healthcare facility/hospital for endoscopy and endoscopic treatment within the lower digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard colonoscopy systems. The PeerScope system model provides 160° standard front field of view and a 300° wide field of view.
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 lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.
1
Technological characteristics
The technological characteristics of PeerScope system were compared to the characteristics of the predicate device and were found very similar, in terms of: endoscope geometry, illumination type, energy source, lens irrigation, air flow and air pressure. Several differences were observed and are listed below:
K1202
| Category | ProtectiScope
CS K081004 | PeerScope System | Impact of the differences on
device performance |
|------------------------------------------------------|----------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Brightness Control | Automatic or
Manual | Factory Adjusted | Factory Adjusted method provides
reliable design without
compromising performance. |
| Output Video
signals | VBS 2 channels
Y/C 2 channels
DVI 2 channels | Composite 3
channels
Y/C 3 channels | Both devices utilized industry
accepted standard Output Video
signals. |
| Foot Switch | Included | Not Included | The foot switch is used to operate
the ProtectiScope CS unique
feature which is not included in the
PeerScope System specifications. |
| Water Flow rate for
Auxiliary Jet water
supply | 20 cc/sec | 4.0 cc/sec | The design of the reduced jet water
flow has been verified & validated.
The results demonstrated that the jet
irrigation is efficient. |
| Disposable Sleeve | Included | Not Included | The disposable sleeve is a unique
feature which is not included in
the PeerScope System
specifications. |
Based on the results of verification, validation and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for its intended use.
Performance data
Bench data:
The device safety and performance were verified by tests by PeerMedical and accredited third party laboratories. List of standards was used / relied upon for testing:
IEC 60601-1: 1988 + Am. #1 (1991), #2 (1995) IEC 60601-2-18:1996 /EN 60601-2-18:1996 2nd Ed. +Am.1 (2000) IEC 60601-1-2:2007 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2007 Part #12 ISO 8600-4 First edition 1997-07-01 ISO 8600-1 Second edition 2005-05-01 ISO 8600-3 First edition 1997-07-01 Am 1 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)
2
K120289 page 3 of 3
Reprocessing validation was carried out in accordance with " Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance / May 2011.
The device performance was validated by testing of a final production unit in simulated clinical conditions focusing on evaluation of the device wide 300° field of view. The procedure was performed by physicians at three US medical centers. Methods and procedures were identical to those used in clinical conditions. The results of the bench validation passed the experiment criteria. The device met its intended use and specifications. Hazardous conditions were not observed.
Clinical Data:
The device performance was validated by testing of a final production unit in clinical conditions. The procedure was performed at Elisha Medical Center, Haifa, Israel on a diverse adult population in terms of gender, ethnicity and age. The procedure was performed by US, European and Israeli physicians. Methods and procedures were identical to those used in USbased studies. Fifty (50) patients were enrolled in conformance with the device labeling. The results of the clinical validation passed the experiment criteria. No adverse events were observed.
The conclusions drawn from the bench and clinical tests demonstrate that the device meets its specifications, intended use and indication for use.
Substantial Equivalence
The above presented data demonstrate that:
- The predicate device ProtectiScope CS -K081004 is legally marketed. a.
- The PeerScope System and the predicate device have the same intended use. b.
- The PeerScope System does not raise different questions of safety and C. effectiveness.
- The data provided demonstrate equivalence and support the indications. d.
Conclusion: It is the opinion of PeerMedical that the PeerScope system is substantially equivalent to the predicate device, in terms of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. In the center of the seal is a stylized image of an eagle or other bird with its wings spread, with the body and wings formed by thick, curved lines. The image is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002
2 8 2012
PeerMedical Ltd.
% Mr. Dan Laor
Quality & Regulatory Advisory
6 Sireni
HAIFA 32972
ISRAEL
Re: K120289
Trade/Device Name: PeerScope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: August 14, 2012 Received: August 15, 2012
Dear Mr. Laor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion 310(t) presidentially equivalent (for the indications ferenced above and nave colorizes ally marketed predicate devices marketed in interstate for the stated in the encrosule) to regars mannent date of the Medical Device American Cruze commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been rochasinou in accessariou of a premarket approval application (PMA). alla Cosmetic Hot (110) market the device, subject to the general controls provisions of the Act. The I ou may, merciolo, market the device, books of the requirements for annual registration, listing of general controls provisions of the fisc labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract lability adulteration. Trease note. CDICT does inst bevice labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 above) and in the major regulations affecting your device can be It may be subject to additional consols. Entrally - 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 Please be advised that I DA 3 issuation of a brander complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decornmance and regulations administered by other Federal agencies. You must or ally Federal statutes and regulations , including, but not limited to: registration and listing comply with an the Act 3 requirements, moradaily, strenging (reporting (reporting of medical
4
Page 2-
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse evones) (21 OFF 003), good many and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 10 forth in the quality by brounds (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 11 you desire specific actives for your actives/CDRH/CDRHOffices/ucm115809.htm for go to mp.nww.ida.gov/rtbound2123.cal Health's (CDRH's) Office of Compliance. Also, please the comer for DOY.cos and "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 I ou may obtain other general incomment one 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,
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
5
Indications for Use
K120289 510(k) Number (if known):
Device Name: PeerScope System
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 lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
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