(267 days)
No
The device description and performance studies focus on the physical and optical properties of the endoscope and its accessories, with no mention of AI or ML capabilities.
Yes
The device is used for the disintegration and removal/extraction of kidney stones, which is a direct treatment of a medical condition.
No
The device is used for the "disintegration and removal / extraction of kidney stones" and facilitates instruments for this purpose, indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the device includes a rigid, reusable endoscope (nephroscope) and accompanying accessories such as sheaths, obturators, and bridges, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Schoelly Nephroscope Set and Ultra-Mini Nephroscope Set are described as instruments used for the disintegration and removal/extraction of kidney stones directly from the body. This is a surgical/interventional procedure, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states the purpose is for the physical removal of kidney stones under endoscopic control.
- Device Description: The description details a rigid endoscope and accessories for accessing and manipulating within the kidney, consistent with a surgical tool.
Therefore, the Schoelly Nephroscope Family falls under the category of surgical instruments or endoscopes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
Product codes (comma separated list FDA assigned to the subject device)
FGA, FEC, FED
Device Description
The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".
Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.
In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.
The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The nephroscopes of the proposed Schoelly Nephroscope Family were subjected to temperature, optical parameter and biocompatibility testing.
Temperature testing: the devices were measured for surface temperatures at various locations as long as a steady state temperature was reached using different light sources and found to meet requirements as specified in IEC 60601-2-18.
Optical parameter testing: The devices were tested for all relevant optical parameters, e.g. field of view and direction of view accuracy and found to meet requirements as specified in ISO 8600.
Biocompatibility testing: A series of biocompatibility testing according to ISO 10993, including cytotoxicity, sensitization, and acute systemic toxicity, demonstrated that the device components that are in contact with the patient are biocompatible.
Reprocessing: The Schoelly Nephroscope Family was the subject of completed reprocessing validations including manual cleaning, automated cleaning and steam sterilization.
Cleaning studies have been performed in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices), and ANSI/AAMI ST15883-1: 2009 (Washer-disinfectors - Part 1 - General requirements, terms, and definitions and tests).
Sterilization studies have been performed in accordance with ISO 14937:2009 (Sterilization of health care products - General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI ST81:2004 (Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices), ISO 17664:2004 (Sterilization of medical devices -Information to be provided by the manufacturer for the processing of resterilizable medical devices), and ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices).
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.
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.
K963855, K940594, K072521, K142249
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Schoelly Fiberoptic, GmbH Dr. Sandra Baumann Senior Manager Regulatory Affairs Robert-Bosch-Str. 1-3 79211 Denzlingen Germany
Re: K151308
Trade/Device Name: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: FGA, FEC, FED Dated: December 23, 2015 Received: December 28, 2015
Dear Dr. Sandra Baumann,
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. 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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
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Indications for Use
510(k) Number (if known) K151308
Device Name Schoelly Nephroscope Set Schoelly Ultra-Mini Nephroscope Set
Indications for Use (Describe)
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
| 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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02/08/2016 Schoelly Nephroscope Family
Section 5 – 510(k) Summary
I. SUBMITTER
Owner's Name: Address:
Telephone Number: Fax Number: Contact Person:
Schoelly Fiberoptic GmbH (Registration: 8043903) Robert-Bosch-Str. 1 - 3 79211 Denzlingen Germany +49-7666-980-0 +49-7666-908-380 Dr. Sandra Baumann
II. DEVICE Subject Device Name: Trade Name:
Common/Usual Name: Classification Name:
Schoelly Nephroscope Family Schoelly Nephroscope Set Schoelly Ultra-Mini Nephroscope Set Nephroscope Set FGA – Kit, Nephroscope 21 CFR 876.1500; Class II FEC - Obturator, for Endoscope 21 CFR 876.1500; Class II FED - Endoscopic Access Overtube, Gastroenterology-Urology 21 CFR 876.1500; Class II
III. PREDICATE/REFERENCE DEVICES
| Predicate Device Name: | Nephroscope Set |
|---|---|
| Trade Name: | Nephroscope Set |
| Common/Usual Name: | Nephroscope Set |
| Classification Name: | FGA - Kit, Nephroscope |
| 21 CFR 876.1500; Class II | |
| FEC - Obturator, for Endoscope | |
| 21 CFR 876.1500; Class II | |
| FED - Endoscopic Access Overtube, | |
| Gastroenterology-Urology | |
| 21 CFR 876.1500; Class II | |
| FFL - Ureteral stone dislodger | |
| 21 CFR 876.4680; Class II | |
| Premarket Notification: | K994223, Richard Wolf Medical Instruments Corp., |
| SE date June 5, 2000 | |
| Recalls: | This predicate has not been subject to a design- |
| related recall | |
| Reference Device Name: | 12 Ureteroscopes/Ureterorenoscopes |
| Trade Name: | Compact Operating Fiber Uretero-Renoscopes |
| Common/Usual Name: | Ureteroscopes |
| Classification Name: | FGB - Ureteroscope and accessories, flexible/rigid |
| 21 CFR 876.1500; Class II | |
| Premarket Notification: | K963855, Richard Wolf Medical Instruments Corp, |
| SE date April 3, 1997 | |
| Reference Device Name: | Karl Storz Adult and Pediatric Nephroscope |
| Trade Name: | Karl Storz Adult and Pediatric Nephroscope |
| Common/Usual Name: | Nephroscope |
| Classification Name: | FGA - Kit, Nephroscope |
| 21 CFR 876.1500; Class II | |
| Premarket Notification: | K940594, Karl Storz Endoscopy America, |
| SE date September 09, 1994 | |
| Reference Device Name: | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath |
| Trade Name: | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath |
| Common/Usual Name: | Access Sheath |
| Classification Name: | FED - Endoscopic Access Overtube, Gastroenterology- |
| Urology | |
| 21 CFR 876.1500; Class II | |
| FFS - Image, illumination, fiberoptic, for endoscope | |
| 21 CFR 876.1500; Class II | |
| FAJ - Cystoscope and accessories, flexible/rigid | |
| 21 CFR 876.1500; Class II | |
| FGA - Kit, Nephroscope | |
| 21 CFR 876.1500; Class II | |
| GCJ - Laparoscope, general & plastic surgery | |
| 21 CFR 876.1500; Class II | |
| FGB - Ureteroscope and accessories, flexible/rigid | |
| 21 CFR 876.1500; Class II | |
| Premarket Notification: | K072521, Cook Urological, Inc., |
| SE date November 20, 2007 | |
| Reference Device Name: | Schoelly Sinuscope |
| Trade Name: | Schoelly Sinuscope |
| Common/Usual Name: | Sinuscope |
| Classification Name: | EOB - Nasopharyngoscope (flexible or rigid) |
| 21 CFR 874.4760; Class II | |
| Premarket Notification: | K142249, Schoelly Fiberoptic GmbH, |
| SE date January 27, 2015 |
In addition to the Richard Wolf predicate device, the following reference devices were used in this submission to support substantial equivalence and to further outline technological characteristics:
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5
IV. DEVICE DESCRIPTION
The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".
Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.
In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.
The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.
Technological Characteristics
Endoscopes (Nephroscopes):
Light that is created by an external light source is transmitted from the nephroscope light guide connector through the nephroscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid rod lens system and a fiber optic bundle. The image can be displayed by a camera/monitor system which can be connected to the nephroscope eyepiece.
The main technical parameters that characterize the optical view of the nephroscopes of both application sets are the direction of view (0°-8°) and the field of view (85°). The insertion tube diameter of the nephroscopes is 6Fr - 19Fr and the insertion tube working length is 220mm.
The nephroscope of the Schoelly Nephroscope Set incorporates a working channel with a max. inner lumen capacity of 9Fr and is used in conjunction with an instrument bridge that is mounted to the nephroscope's proximal end (see "Bridges" Section below).
The nephroscope of the Schoelly Ultra-Mini Nephroscope Set does not have a working channel and is not equipped with an instrument bridge but is accompanied by additional accessories instead. The design of those accessories ensures that if the nephroscope is used in conjunction with them, the setup provides exactly the same functionality. Thus, if assembled appropriately, both application sets incorporate the number of inner lumens required to perform each single step of the intervention and to accommodate auxiliary instruments and irrigation.
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Like other currently marketed nephroscopes, all Schoelly configurations have outer surfaces mainly made from stainless steel and further comprise fiber optics for light transmission and rigid rod lenses and fiber optics for image transmission.
Sheaths:
The endoscopic sheaths included in this submission are rigid reusable instruments with inner lumens and mainly made from stainless steel; the sheaths serve as the most outer part of the whole device setup in PCNL and Mini PCNL procedures. The proximal end of the endoscopic sheaths is equipped with one side port for irrigation. The outer diameter of the sheaths in this submission ranges from 11Fr-24Fr to comply with the different nephroscopes and obturators of the proposed Family.
Obturators
The obturators included in this submission are rigid reusable instruments mainly made from stainless steel with an inner lumen sized to accept the needed guide wire (not part of this submission) for correct placement of the sheath in the kidney. During insertion, the obturator fills the space inside the sheath to provide a smooth surface. The overall length of the obturators and their diameter comply with the length and the diameter of the available sheaths.
Bridges:
This submission includes a standard instrument bridge, which is a rigid reusable instrument with an inner lumen and mainly made from stainless steel. It includes ports to allow for insertion of instruments and irrigation through the working channel of the nephroscope of the Schoelly Nephroscope Set. Channels can be sealed with a self-sealing membrane and a stop cock, respectively. It comprises an automatic locking mechanism for easy connection to the proximal end of the nephroscope.
V. INDICATIONS FOR USE
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
VI. COMPARISON OF TECHNOLOGCIAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Indications for Use for the proposed Schoelly Nephroscope Family comprises a subset of the Indications for Use of the predicate device. Since the proposed Schoelly Nephroscope Family is not intended to be used via transurethral access as is the case for the Richard Wolf predicate device, the removal/extraction of bladder stones is not included in the Indications for Use for this submission. Remaining contents of the Indications for Use are identical for the proposed and the predicate device.
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| Technological Characteristics: Similarities and Differences between the Proposed Device and the Predicate Devices | |||
|---|---|---|---|
| Attribute | Proposed | ||
| Nephroscope Family | |||
| (current submission) | Endoscope (Nephroscope) | Predicate | |
| Richard Wolf Nephroscope Set (K994223) | |||
| Light transmission | Fiber optics | Fiber optics | Fiber optics |
| Light source | External, connected via light guide to light guide connector | External, connected via light guide to light guide connector | External, connected via light guide to light guide connector |
| Image transmission | Rigid rod lenses + fiber optics | Rigid rod lenses, rigid rod lenses + fiber optics | Rigid rod lenses, rigid rod lenses + fiber optics |
| Eyepiece orientation | angled, straight | angled, angled offset | angled, angled offset |
| Direction of view | 0°-8° | 12°-25° | 12°-25° |
| Field of view | 85° | 95° (Richard Wolf Long Miniature Endoscope) | 95° (Richard Wolf Long Miniature Endoscope) |
| Image display | Camera/monitor connected via the endoscope eyepiece | Camera/monitor connected via the endoscope eyepiece | Camera/monitor connected via the endoscope eyepiece |
| Insertion tube working length | 220mm | 175-225mm | 175-225mm |
| Insertion tube outer diameter | 6Fr-19Fr | 15Fr-27Fr | 15Fr-27Fr |
| Inner lumen capacity | max.3 Fr- max. 9 Fr | max. 6Fr - max.12Fr | max. 6Fr - max.12Fr |
| Single Use / Reusable | Reusable | Reusable | Reusable |
| Reprocessing | Cleaning, sterilization (steam) | Cleaning, sterilization (steam, H2O2) | Cleaning, sterilization (steam, H2O2) |
| Patient contacting materials | Stainless steel, glass, glass fibers, adhesive | Stainless steel, glass, glass fibers, adhesive | Stainless steel, glass, glass fibers, adhesive |
| Electrical safety | IEC 60601-2-18 compliant | IEC 60601-2-18 compliant | IEC 60601-2-18 compliant |
| Instruments | |||
| Sheath outer diameter | 11Fr-24Fr | 15Fr-27Fr | 15Fr-27Fr |
| Obturator outer diameter | Compatible with 11Fr-24Fr sheath | Compatible with 15Fr-27Fr sheath | Compatible with 15Fr-27Fr sheath |
| Single Use / Reusable | Reusable | Reusable | Reusable |
| Reprocessing | Cleaning, sterilization (steam) | Cleaning, sterilization (steam, H2O2) | Cleaning, sterilization (steam, H2O2) |
| Patient contacting materials | Stainless steel, silicone, tin/silver alloy | Stainless steel, silicone | Stainless steel, silicone |
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VII. PERFORMANCE DATA
The nephroscopes of the proposed Schoelly Nephroscope Family were subjected to temperature, optical parameter and biocompatibility testing.
Temperature testing: the devices were measured for surface temperatures at various locations as long as a steady state temperature was reached using different light sources and found to meet requirements as specified in IEC 60601-2-18.
Optical parameter testing: The devices were tested for all relevant optical parameters, e.g. field of view and direction of view accuracy and found to meet requirements as specified in ISO 8600.
Biocompatibility testing: A series of biocompatibility testing according to ISO 10993, including cytotoxicity, sensitization, and acute systemic toxicity, demonstrated that the device components that are in contact with the patient are biocompatible.
Reprocessing
The Schoelly Nephroscope Family was the subject of completed reprocessing validations including manual cleaning, automated cleaning and steam sterilization.
Cleaning studies have been performed in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices), and ANSI/AAMI ST15883-1: 2009 (Washer-disinfectors - Part 1 - General requirements, terms, and definitions and tests).
Sterilization studies have been performed in accordance with ISO 14937:2009 (Sterilization of health care products - General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI ST81:2004 (Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices), ISO 17664:2004 (Sterilization of medical devices -Information to be provided by the manufacturer for the processing of resterilizable medical devices), and ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices).
VIII. CONCLUSION
The Schoelly Nephroscope Family meets all the pre-determined testing and acceptance criteria to effectively demonstrate substantial equivalence to the predicate device.