(324 days)
Cyber BLADE is intended for use under endoscopic visualization and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
Cyber Blade provides efficient and rapid morcellation under endoscopic visualization. The cutting action is driven by the motor in the handpiece. Cyber Blade comprises: a single use sterile blade fixed to a handpiece where controls are placed, a re-usable internal motor provided with integrated battery pack, an AC powered charger for the battery pack. Cyber blade is also supplied with aspiration tubing and canister for the collection of evacuated tissue.
I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document refers to the Cyber Blade, which is a medical device for morcellation and removal of BPH tissue, but it does not contain information about acceptance criteria or performance studies with human subjects or AI.
The text primarily details:
- The FDA's 510(k) clearance for the Cyber Blade, indicating substantial equivalence to predicate devices.
- Device description, technical specifications, and comparison to predicate devices.
- A list of recognized consensus standards and guidelines that the device complies with (e.g., related to electrical safety, biocompatibility, sterilization, packaging, risk management, and software).
- Additional types of testing performed (morcellation efficiency, suction test, dimensional verification, tensile strength, comparative testing with a specific morcellator, risk analysis on performance tests, and battery testing).
None of these sections provide:
- A table of acceptance criteria and reported device performance for a study.
- Sample sizes or data provenance for studies involving performance against acceptance criteria.
- Details about experts or ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or ground truth establishment for a training set.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical trial data or performance against specific, quantifiable acceptance criteria often seen for novel devices or software with complex performance claims (like AI). The "performance testing" mentioned refers to engineering tests against established standards and product specifications, not clinical outcomes or diagnostic accuracy studies.
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July 31, 2020
SIDAM s.r.1. Andrea Tromba Regulatory Affairs Manager Via Statale Sud, 169 Mirandola (MO), 41037 Italy
Re: K192499 Trade/Device Name: Cyber Blade Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: June 18, 2020 Received: June 22, 2020
Dear Andrea Tromba:
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,
Martha W. Betz, Ph.D. Acting 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) K192499
Device Name Cyber Blade
Indications for Use (Describe)
Cyber BLADE is intended for use under endoscopic visualization and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(K) SUMMARY
| Applicant /ManufacturerName and Address: | SIDAM s.r.l.Via Statale Sud, 16941037 San Giacomo RoncoleMIRANDOLA (MO) - Italy |
|---|---|
| 510(k) Contact Person: | Andrea TrombaRegulatory Affairs ManagerSIDAM s.r.l.Email: andrea@sidamit.itPhone: +39 0535.25523Fax:+39 0535.25635 |
| Date Prepared: | 31/07/2020 |
| Device Name: | Cyber Blade |
| Classification: | Class II |
| Classification Name: | Endoscopes and accessories |
| Common name: | Laparoscope, General and Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Main Predicate deviceSecondary predicate device | Versacut + Tissue Morcellator (K133272), Lumenis LtdMorce Scope Set 8970 (K041610), Richard Wolf MedicalInstruments Corp. |
Performance Standards:
There are no mandatory performance standards for this device.
Description of the device:
Cyber Blade provides efficient and rapid morcellation under endoscopic visualization. The cutting action is driven by the motor in the handpiece.
Cyber Blade comprises:
- a single use sterile blade fixed to a handpiece where controls are placed
- a re-usable internal motor provided with integrated battery pack
- an AC powered charger for the battery pack
Cyber blade is also supplied with aspiration tubing and canister for the collection of evacuated tissue.
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| REF | Description | notes |
|---|---|---|
| 20041001 | Cyber Blade Morcellator | sterile single use |
| 20042001 | Battery-powered motor | non sterile - reusable |
| 20049001 | Charging station | 100-220V, 50/60Hz |
| ABM000091 | Suction tube | sterile single use |
| 077.0562 | Canister (tissue collector) |
Cyber Blade is comprehensive of the following parts:
| Key Specifications, mechanism of action, device function | |
|---|---|
| Principle of operation | morcellation through the cutting effect of the cutting window, produced by the relative movement of the internal tube and the external tube. |
| Vacuum intensity regulation | Possible through the leverage on the morcellator |
| Speed regulation | Possible through the button on the morcellator |
| Morcellation velocity 1 | About 17 grams per minute |
| Handpiece dimension (external tube) | 38 cm length0.47 cm external diameter |
| Materials in contact with the tissue | Stainless steel |
| Power supply | The morcellator is battery powered.The battery charger is AC power supplied. |
| Supplied Sterile | Yes (only the morcellator) |
| Re-usable | No. The morcellator is single use only.Its internal motor is reusable |
Indications for Use
Cyber BLADE is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
Comparison of Technological Characteristics:
The subject device and the identified predicate devices have comparable general intended use and technological characteristics.
Any differences compared to the predicate devices do not present any new types of safety or effectiveness concern.
A comparison of the technical characteristics between the subject and predicate devices follows:
1 The morcellated tissue coincides with the removed tissue, as all is aspired with the vacuum system
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| Specification | Subject device | main predicate device | Secondary predicate device | Comparison to Predicate |
|---|---|---|---|---|
| Device Name(K #) | Cyber Blade | VERSACUT + TISSUEMORCELLATOR (K133272) | MORCE SCOPE SET 8970(K041610) | |
| Submitter | SIDAM s.r.l. | LUMENIS LTD. | RICHARD WOLF MEDICALINSTRUMENTS CORP. | |
| Principle of operation | morcellation through the cuttingeffect of the cutting window,produced by the relativemovement of the internal tubeand the external tube. | Morcellation through the cuttingeffect of the cutting window,produced by the relativemovement of the internal tubeand the external tube. | Morcellation through the cuttingeffect of the cutting window,produced by the relativemovement of the internal tubeand the external tube. | Same |
| Vacuum intensityregulation | Possible through the leverage onthe morcellator | Possible from the vacuumgenerator | Possible from the vacuumgenerator | equivalent |
| Speed regulation | Possible through the button onthe morcellator | Possible from the vacuumgenerator | Possible from the vacuumgenerator | equivalent |
| Handpiece dimension(external tube) | 38 cm length0.47 cm external diameter | 39.5 cm length0.47 cm external diameter | 35 or 38 cm length0.475 cm external diameter | In the same range |
| Materials in contactwith the tissue | Stainless steel | Stainless steel | Stainless steel | equivalent |
| Power supply | The morcellator is batterypowered.The battery charger is AC powersupplied. | AC power supplied | AC power supplied | A device battery poweredraises less concerns comparedto a device AC powered |
| Suction pump | Not part of the system, must usean external suction system. | Part of the system | Part of the system | External FDA cleared suctionsystem to be used. |
| Supplied Sterile | Yes | No | Yes | A device provided sterile raisesless concerns compared to adevice intended to be sterilizedbefore use. |
| Re-usable | No. The morcellator is single useonly.Its internal motor is reusable,but it never comes in contactwith the patient | Yes | Available either single use andreusable | A single use device raises lessconcerns than a re-usable one. |
Comparison of indications: as detailed in the comparison table below, the indications of the subject device are a sub-set of the indications of its predicate devices.
| Specification | Subject device | main predicate device | additional predicate device | Comparison to Predicate |
|---|---|---|---|---|
| Device Name(K #) | Cyber Blade | VERSACUT + TISSUEMORCELLATOR (K133272) | MORCE SCOPE SET 8970(K041610) | |
| Submitter | SIDAM s.r.l. | LUMENIS LTD. | RICHARD WOLF MEDICALINSTRUMENTS CORP. | |
| Intended use | Cyber BLADE is intended for useunder endoscopic visualizationfor the morcellation andremoval of dissected benignprostatic hyperplasia (BPH)tissue during endoscopic surgicalprocedures in urology. | The VersaCut + TissueMorcellator is intended for useunderdirect or endoscopicvisualization for themorcellation and removalof dissected tissue duringpelviscopic, laparascopic,percutaneousand open surgical procedureswhenever access to the surgicalsite is limited. | MORCE Scope Set 8970, inconjunction with amorcellation probe, and withits sheaths and obturators, isused in the cutting(morcellation) and continuousremoval of large tissue masses.In combination with thecorresponding auxiliaryinstruments, it can be used as anephroscope in thedisintegration andremoval/aspiration of kidneyand bladder stones andthe removal of tumors viapercutaneous (kidney) ortransurethral (bladder)passages, in conjunction with | Sub-set of the indications ofthe predicate devices.Endoscopy is a less invasiveaccess to the body comparedto laparoscopy or otherinvasive techniques. |
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| Specification | Subject device | main predicate device | additional predicate device | Comparison to Predicate |
|---|---|---|---|---|
| Device Name(K #) | Cyber Blade | VERSACUT + TISSUEMORCELLATOR (K133272) | MORCE SCOPE SET 8970(K041610) | |
| Submitter | SIDAM s.r.l. | LUMENIS LTD. | RICHARD WOLF MEDICALINSTRUMENTS CORP. | |
| intracorporeal 5-4ithotripterse.g. operated pneumatically,by ultrasound, electro-hydraulically or by laser, underendoscopic control.The POWER CONTROL 2303 inconjunction with POWER STICKM4 serves to drive WOLFmorcellators for thecontinuous removal of ablatedtissue in endoscopicoperations.The SUCTION PUMP is used foraspirating irrigation fluid inconjunction with aresectoscope or a morcellatorfollowing laser TURP. |
Summary of Non-Clinical Performance Testing :
Cyber Blade devices comply with the following recognized consensus standards or guidelines:
| STANDARD TITLE or guidelines | standardrecognizedby FDA? | FDArecognitionnumber | exclusionsfrom thestandard |
|---|---|---|---|
| IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1:General Requirements For Basic Safety And Essential Performance | Yes | 19-4 | No |
| IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance- Collateral Standard: Electromagnetic Compatibility - RequirementsAnd Tests | Yes | 19-8 | No |
| EN 556-1:2001/AC:2006 Sterilization of medical devices –Requirements for medical devices to be designated "STERILE" – Part1: requirements for terminally sterilized medical devices | No | N/A | No |
| ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols tobe used with medical device labels, labelling, and information to besupplied - Part 1: General requirements | Yes | 5-117 | No |
| EN 1041:2008 Information supplied by the manufacturer of medicaldevices. | No | N/A | No |
| ISO 10993-5 Third edition 2009-06-01 Biological evaluation ofmedical devices - Part 5: Tests for in vitro cytotoxicity | Yes | 2-245 | No |
| ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a riskmanagement process [Including: Technical Corrigendum 1 (2010)] | Yes | 2-220 | No |
| STANDARD TITLE or guidelines | standardrecognizedby FDA? | FDArecognitionnumber | exclusionsfrom thestandard |
| ISO 10993-7 Second edition 2008-10-15 Biological evaluation ofmedical devices - Part 7: Ethylene oxide sterilization residuals[Including: Technical Corrigendum 1 (2009)] | Yes | 14-408 | No |
| ISO 10993-10 Third Edition 2010-08-01 Biological evaluation ofmedical devices - Part 10: Tests for irritation and skin sensitization | Yes | 2-174 | No |
| ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development,validation and routine control of a sterilization process for medicaldevices [Including: Amendment 1 (2018)] | Yes | 14-529 | No |
| ISO 11138-1 Third edition 2017-03 Sterilization of health careproducts - Biological indicators - Part 1: General requirements | Yes | 14-502 | No |
| ISO 11607-1 First edition 2006-04-15 Packaging forterminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging systems [Including:Amendment 1 (2014)] | Yes | 14-454 | No |
| ISO 11607-2 First edition 2006-04-15 Packaging forterminally sterilized medical devices - Part 2: Validationrequirements for forming, sealing and assembly processes[Including: Amendment 1 (2014)] | Yes | 14-455 | No |
| ISO 11737-1 Third edition 2018-01 Sterilization of health careproducts - Microbiological methods - Part 1: Determination of apopulation of microorganisms on product | Yes | 14-514 | No |
| ISO 14971 Second edition 2007-03-01 Medical devices -Application of risk management to medical devices | Yes | 5-40 | No |
| ISO 17664 Second edition 2017-10 Processing of health careproducts - Information to be provided by the medical devicemanufacturer for the processing of medical devices | Yes | 14-515 | No |
| ISO 17664 Second Edition 2017-10 Processing Of Health CareProducts - Information To Be Provided By The Medical DeviceManufacturer For The Processing Of Medical Devices | Yes | 14-515 | No |
| Software Verification and Validation TestingSoftware verification and validation testing were conducted anddocumentation was provided as recommended by FDA's Guidancefor Industry and FDA Staff, "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices | - | - | - |
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The following additional testing were performed: morcellation efficiency, suction test, dimensional specification verification, tensile strength of blade, comparative testing with Richard Wolf morcellator, risk analysis on the performance test, battery testing.
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Conclusion
As the indications for use are a sub-set of its predicate devices and the principle of operation and specifications are equivalent, Cyber Blade is substantially equivalent to its predicate devices.
§ 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.