Resascope RS-01/B

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December 21, 2020 Advanced Medical Systems Group SRL Francesco Sgarbi R&D Manager Via Europa 12 35020 San Pietro Viminario, Padova Italy Re: K201113 Trade/Device Name: Resascope RS-01/B Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 18, 2020 Received: November 25, 2020 Dear Francesco Sgarbi: 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. You must comply with all the Act's {1}------------------------------------------------ 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201113 Device Name Resascope RS-01/B Indications for Use (Describe) When used with a fibreoptic endoscope, Resascope is a video guided catheter intended to be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | <span> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary ## Applicant: | Company Name: | Advanced Medical Systems Group SRL | |--------------------------------------|---------------------------------------| | Company Address: | Via Europa 12 | | | 35020 | | | San Pietro Viminario (Padova) - Italy | | Company Phone: | +39 049 9719511 | | Company Fax: | +39 049 9719542 | | Official Contact for Correspondence: | Francesco Sgarbi | | Phone: | +39 0429 719378 | | E-mail: | sgarbi@amsvita.com | | Date Summary Prepared: | November 18, 2020 | | DEVICE IDENTIFICATION | | | Trade name: | Resascope RS-01/B | | Generic/ Common Name: | Video guided catheter | | Classification: | 21 CFR§ 888.1100, Class II | | Classification name: | Arthroscope | | Product Code: | HRX | | Panel: | Orthopedic | #### PREDICATE DEVICE: Myelotec video guided catheter, Myelotec Inc, K980734 #### DEVICE DESCRIPTION The Resascope video guided catheter can be used in the lumbar and sacral epidural space to view the epidural anatomy, the pathology and to deliver approved drugs for epidural administration. It can also be used by physicians to light and view the tissues in the epidural space of the lumbar and sacral spine, and in order to assist in the diagnosis of related pathologies, using a percutaneous approach through the sacral hiatus. It is designed to be used by trained medical staff for less than 60 minutes usage time period. lt is design with a soft tip and the addition of some blocks inside that allow the catheter to remain locked and therefore oriented, without return to zero. The medical device is basically structured by two parts: the orientable catheter, intended to enter the peridural space, and the knob, to be used for the orientation of the catheter tip (tip flexion); on the knob there are connection tubes for inserting the endoscope and for connection to the infusion sets. {4}------------------------------------------------ ## INDICATIONS FOR USE When used with a fibreoptic endoscope, Resascope is a video guided catheter intended to be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications. ## DISCUSSION OF NON-CLINICAL TESTS Non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the applicable sections of the standards listed below: #### Biocompatibility The materials used to manufacture the subject device are largely used for other legally marketed devices under the same product code as the submitted Resascope RS-01/B. Biocompatibility has been tested according to the requirements of ISO 10993-1:2018, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The following biocompatibility tests were performed: - Cytotoxicity, ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity - Sensitization and Intracutaneous reactivity, ISO 10993-10: 2010 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization. - Acute Systemic Toxicity, ISO 10993-11:2006 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity - Haemolysis, ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, ASTM F756-17, Standard practice for assessment of hemolytic properties of materials, ASTM F-619-14, Standard Practice for Extraction of Medical Plastic. - Hemocompatibility, ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, ASTM F2888-19, Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials, ASTM F2382-18, Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT). #### Sterilization Validation A sterilization validation process was performed on the subject device according to Recognized Consensus Standard: ISO 11135:2014, Sterilization of health-care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices. ISO 11138-1: 2017, Sterilization of health care products - Biological indicators - Part 1: General requirements; ISO 10993-7 :2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; ISO 11737-2 :2009, Sterilization of medical devices -- Microbiological methods- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. The method used to make the determination of non pyrogenicity was Bacterials Endotoxines by LAL test and Rabbit pyrogen test. LAL test was performed according to: - LAL test/USP chapter <85> Bacterial Endotoxins Test. - ANSI/AAMI ST72 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, - European Pharmacopoeia current edition: 2.6.14 Bacterial Endotoxins. Pyrogen Test was performed in compliance with: - ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part1: Evaluation and Testing within a Risk Management Process - ISO 10993-2:2006 "Biological Evaluation of Medical Devices Part 2: Animal welfare requirements" - ISO 10993-11 "Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity" - ISO 10993-12:2012 "Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials". - U.S. Pharmacopoeia, 2011 USPC Official and General Chapters: <151> Pyrogen test. {5}------------------------------------------------ Benching tests The performances of the Resoscope video guided catheter are tested as follows: Tensile Test to verify the tensile of the shaft welded joints and strain relief bond Bend Test to verify the proper functioning of the Resascope wheels control Leak Test to verify there is no leakage in the device Lock Test to verify the locking mechanism operates correctly ## SUBSTANTIAL EQUIVALENCE The Resacope RS-01/B is same or similar in intended use, design and operating principles to the predicate device (K980734). Both the subject and the predicate device are indicated for use in clinical environments. Both the devices have the same principle of operation, same overall design; the same method of use and limited duration of contact with the patient; similar sizes of the catheter. The minor differences in design do not raise any new types of safety or effectiveness questions. Performance data (design verification testing) demonstrate that the subject device is as safe and effective as the cited predicate. In further support of a substantial equivalence determination, hereunder is a comparison chart with the submitted device and the predicate device. | SPECIFICATIONS &<br>CHARACTERISTICS | | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject device | K980734 | | | Manufacturer | Advanced Medical Systems<br>Group SRL | Myelotec Inc | | | Device Name | Resascope RS-01/B | Myelotec video guided catheter | | | Common name | Video guided catheter | Video guided catheter | same | | Indications For Use | When used with a fibreoptic<br>endoscope, Resascope is a video<br>guided catheter intended to be<br>used in the lumbar and sacral<br>spine for observing epidural<br>anatomy, pathology and delivery<br>of drugs approved for epidural<br>indications. | When used with a fibreoptic<br>endoscope, this device can be<br>used in the lumbar and sacral<br>spine for observing epidural<br>anatomy, pathology and delivery<br>of drugs approved for epidural<br>indications | same | | Type of use | Prescription Use (Part 21 CFR<br>801 Subpart D) | Prescription Use (Part 21 CFR<br>801 Subpart D) | same | | Product Code | HRX | HRX | same | | Classification | 21 CFR 888.1100 Arthroscope | 21 CFR 888.1100 Arthroscope | same | | Intended User | The device is to be used by trained personnel only | The device is to be used by trained personnel only | same | | Intended Environment | Medical centers | Hospital/surgery center | substantially equivalent | | Sterile | yes | yes | same | | Single use | yes | yes | same | | Design | two parts: the orientable catheter intended to enter the peridural space and the knob for the orientation of the catheter, connection tubes on the knob for visualization through endoscope and for connection to the infusion sets, soft tip, radiopaque distal tip, steel wires in the catheter body render it visible in X-rays | two parts: the orientable catheter intended to enter the peridural space and the knob for the orientation of the catheter, connection tubes on the knob for visualization through endoscope and for connection to the infusion sets, soft tip, radiopaque shaft | substantially equivalent | | Insertion point | Sacral Hiatus | Sacral Hiatus | same | | Infusion port | 2 | 2 | same | | Catheter Length | 30 cm | 30 cm | same | | Catheter Outer diameter | from 3.3 mm to 3.5 mm | 2.7 mm, 3.0 mm | Substantially equivalent. The difference in the size does not impact safety or effectiveness considering that it is a slight difference also in respect of the mean diameter of the insertion point (sacral hiatus) and the adjacent sacral canal | | Lumen inner diameter | 1.29 mm | 1 mm, 1.3 mm | Substantially equivalent, the size of the lumen inner diameter of the subject device is comprised in the sizes of those of the subject device | | Number of lumens for optics and micro instruments | 2 | 2 | same | | for surgical<br>treatments | | | | | Endoscope capable | yes | yes | same | | Steerable | yes | yes | same | | Catheter tube<br>Materials | Polyether - Poliammide +<br>Barium Sulfate | not available | The materials used for<br>the components of the<br>device that come in<br>contact with the patient<br>are largely used for<br>medical devices and<br>they have a long history<br>of safe use for the same<br>or equivalent<br>indications. The testing<br>performed on the<br>subject device<br>demonstrate that no<br>issues of safety and<br>effectiveness arise. | | Biocompatibility | Meet requirements for ISO<br>10993-1 | not available | | {6}------------------------------------------------ {7}------------------------------------------------ #### SUBSTANTIAL EQUIVALENCE DISCUSSION: #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Both the medical devices are basically structured by two parts: the adjustable catheter, intended to enter the peridural space, and the knob, to be used for the orientation of the catheter tip; on the handle of both devices there are connection tubes for inserting the endoscope and for connection to the infusion sets. The subject and predicate devices are based on the same or similar technological elements and are made with the materials largely used for the same type of medical devices already on the market. The minor differences in the technological characteristics of the devices do not impact the safety and effectiveness of the subject device. The performance data (design verification testing) demonstrate that the subject device is as safe and effective as the cited predicate. AMS Group believes that the submitted Resascope is substantially equivalent in its intended use, design, materials, function and biocompatibility to the currently cleared device and is therefore as safe and effective. ## CONCLUSION: Based on the available information, we conclude that the Resascope RS-01/B is substantially equivalent to the existing legally marketed device under Federal Food, Drug and Cosmetic Act. Therefore, the subject device is determined to be equivalent to the predicate device.