(277 days)
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.
The provided text is a 510(k) Premarket Notification for the ScalpelCric device, a cricothyrotomy set. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.
However, this document does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system, or a multi-reader multi-case (MRMC) study. The document focuses on the physical and biological characteristics of the medical device itself, its sterilization, biocompatibility, and bench testing, rather than a performance study involving diagnostic accuracy, expert review, or AI assistance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of an AI-assisted diagnostic system, as that information is not present in the provided text.
The closest information related to "acceptance criteria" is under section 9.4 Bench Testing, which lists features to be tested and the result (all "Passed"). This refers to the physical and functional performance of the device components, not a diagnostic or AI-related performance.
Here's what I can extract from the provided text regarding device testing, but it's important to note this is not a study proving AI performance as requested:
1. A table of acceptance criteria and the reported device performance:
The document provides a table under "9.4 Bench Testing" (page 10), which lists various tests performed on the components of the ScalpelCric set. The "Features to be tested" can be considered the acceptance criteria for those specific physical/functional aspects, and the "Result" indicates "Passed" for all.
| Object under Test | Features to be tested (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Bonding Connector | Bonding between connector and tube | Passed |
| Bonding Inflation Line | Bonding between inflation line and tube | Passed |
| 15mm Connector | Dimensions of 15mm Connector | Passed |
| Luer Pilot Balloon | Dimensions of the female luer connector in the pilot balloon | Passed |
| Cuff | Function of the Cuff | Passed |
| Scalpel | Function and design of the scalpel | Passed |
| Bougie | Bougie which shall fulfill all relevant specification according [DI] and [MS_Bougie]. | Passed |
| Tube | Function and dimensions of the tube | Passed |
| Tube | Tube is recognizable in X-Ray images | Passed |
| Extension Tube | Function and dimension of the extension tube | Passed |
| Neck Tape | Neck tape which shall fulfill all relevant specification according [DI] and [MS_NT] after 4 times sterilization | Passed |
| Syringe | Function of the syringe | Passed |
| Tube with inflation line and cuff, | Function and features of the tube with attached inflation line and pilot balloon and with cuff | Passed |
| ScalpelCric | Biological compatibility | Passed |
| Material | Function and ingredient of the ScalpelCric materials | Passed |
| Tube and extension Tube | Oxygen resistance of Tube and Extension tube | Passed |
| Label | Device Label | Passed |
| Bougie | Device Label Bougie | Passed |
| IFU | IFU which shall contain all relevant information regarding [DI] and [ER]. | Passed |
| ScalpelCric | ScalpelCric Set can be used in Operating condition | Passed |
| ScalpelCric | Functionality after simulated transport | Passed |
| Transport Validation | Functionality after simulated transport | Passed |
| Safety | Verify implementation and effectiveness of all Risk Control Measures defined in the Risk Analysis | Passed |
| Suction Cap | Connecting tube with open suction cap during ventilation | Passed |
| User Needs | User Needs for ScalpelCric, defined in [SoP] | Passed |
| ScalpelCric | Usability | Passed |
| Headerbag | Requirements of DIN EN ISO 11607-1 and DIN EN ISO 11607-2. | Passed |
| Sterilization | Sterilization Requirements for ScalpelCric | Passed |
| Business Needs | Business Needs for ScalpelCric | Passed |
| Label Sterile Packaging | Sterile packaging label which shall contain all relevant information regarding the [SFL], [DI] and [ER]. | Passed |
| Label Outer Packaging | Outer packaging label which shall contain all relevant information regarding the [SFL], [DL] and [ER] | Passed |
| Packaging | Packaging Requirements for ScalpelCric | Passed |
| Accelerated Aging Syringe | Quality of the syringe after 5 years accelerated aging | Passed |
| Accelerated aging of Pouch | Function of the sterile packaging after 5 years accelerated aging | Passed |
| Bougie | Bougie shall fulfill all relevant specifications after 1 year accelerated aging | Passed |
| Scalpel | Function of the scalpel after accelerated aging 1 year | Passed |
| ScalpelCric | Scalpel Cric Set application oxygen resistance after 1 year accelerated aging | Passed |
| Surgicric | Function and dimension after 5 years accelerated aging of the Surgicric and the function of the sterile packaging. | Passed |
| Surgicric | are identical to the devices in ScalpelCric. | Passed |
| Surgicric | Function and dimension after 3 years real time aging of the Surgicric including Tubus and the function of the sterile packaging. The tested tube and sterile packaging are identical to the devices in ScalpelCric. | Passed |
| Syringe | Quality of the syringe after 3 years real time aging | Passed |
| Bougie | Bougie shall fulfill all relevant specifications after 5 years accelerated aging | Passed |
| Scalpel | Function of the scalpel after 5 years accelerated aging | Passed |
| ScalpelCric Set | Application oxygen resistance after 5 years accelerated aging | Passed |
| Cuff Tube Collapse included in the ScalpelCric after 5 years of accelerated aging. | Test required by DIN EN ISO 5361:2013-03, Annex C: Resistance of the VBM tracheal tube ventilation lumen collapse with cuff inflated inside a cylinder. | Passed |
The remaining requested information (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set details) is NOT available in the provided document, as it pertains to a different type of device evaluation (e.g., AI/diagnostic performance) than what is described here. This document is focused on the substantial equivalence of a physical medical device (a cricothyrotomy set) to a predicate device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
VBM Medizintechnik GmbH Jannika Jaeger Regulatory Affairs Manager Einsteinstrasse 1 Sulz am Neckar, 72172 De
Re: K200190 Trade/Device Name: ScalpelCric Regulation Number: 21 CFR 868.5090 Regulation Name: Emergency Airway Needle
Regulatory Class: Class II Product Code: BWC, JOH, OGP Dated: September 25, 2020 Received: September 28, 2020
Dear Jannika Jaeger:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (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 medical devices and radiation-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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ScalpelCric Crycothyrotomy set - Scalpel technique
Indications for Use (Describe)
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K200190
VOLUME 003
510(k) Summary
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| DATE OF APPLICATION: | 10/26/2020 |
|---|---|
| APPLICANT: | VBM Medizintechnik GmbHEinsteinstrasse 172172 Sulz a. N.GermanyTel: + 49 (0) 7454 9596 0Fax: +49 (0) 7454 9596 33E-Mail: info@vbm-medical.de |
| CONTACT PERSON: | Jannika JaegerRegulatory Affairs ManagerTel.: + 49 (0) 7454 9596 660 |
E-Mail: jannika.jaeger@vbm-medical.de
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1 Device Name
| Trade Name: | ScalpelCric |
|---|---|
| Common Name: | Cricothyrotomy SetNeedle, Emergency Airway |
| Device Classification Name: | Cricothyrotomy KitTube tracheostomy and tube cuff |
2 Classification / Product Code
ScalpelCric can be classified according to following device name and product code:
Primary Product Code
| Device | RegulationDescription | RegulationMedicalSpecialty | Review Panel | ProductCode | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| Needle,EmergencyAirway | Emergencyairwayneedle. | Anesthesiology | Anesthesiology | BWC | 868.5090 | 2 |
Additional Product ode
| Device | RegulationDescription | RegulationMedicalSpecialty | Review Panel | ProductCode | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| Tubetracheostomyand tube cuff | Tracheostomy tube andtube cuff. | Anesthesiology | Anesthesiology | JOH | 868.5800 | 2 |
Predicate Device / Reference Device ന
| Device | Predicate Device | ReferenceDevice | 510(k)Number | 510(k) Holder |
|---|---|---|---|---|
| Needle, EmergencyAirway | Melker Cuffed EmergencyCricothyrotomy CatheterSet -Percutaneous, MelkerCuffed EmergencyCricothyrotomy CatheterSet - Surgical, MelkerUniversal CuffedEmergency CricothyrotomyCatheter Set | --- | K160200 | COOKINCORPORATED750 DANIELS WAYBloomington,Indiana 47404 |
| --- | AirwayConnectorwith Flex Tube | K942392 | Covidien LlcformerlyMALLINCKRODTDAR S.R.L.15 HAMPSHIRESTREET |
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| Mansfield, MA US 02048 | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------ |
4 Device Description
Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed.
The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.
5 Intended Use
Surgical cricothyrotomy set for securing the airway in case of upper airway obstruction or as ultima ratio if all other attempts to ventilate the patient have failed. ScalpelCric can be used with resuscitation bags or other standard ventilation systems.
Clinical benefit: ScalpelCric allows the ventilation of patients as ultima ratio.
Patient target group: Adults
Location of use: Hospital and pre-hospital conditions including military use
6 Indication for Use
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
7 Mechanism of Action
The device is used for securing the airway in case of upper airway obstruction. After incision of the cricothyroid membrane a bouqie is inserted to allow an easy insertion of the tube over the bougie into the trachea. After bougie removal, inflation of the cuff and fixation of the tube the patient can be ventilated.
8 Technological Characteristics
The technological characteristics of ScalpelCric are substantially equivalent to the technological characteristics of the predicate device or the reference device.
| Company | VBM---ScalpelCric,Cricothyrotomy Set(New Device) | CookIncorporated---Melker CuffedEmergencyCricothyrotomyCatheter Set -Surgical(PredicateDevice) | Covidien IIc---AirwayConnector withFlex Tube(ReferenceDevice) | Result | |
|---|---|---|---|---|---|
| Device Name | Needle, EmergencyAirwayCricothyrotomy kitTube tracheostomy andtube cuff | Needle, EmergencyAirwayCricothyrotomy kitTube tracheostomyand tube cuff | Airway Connectorwith Flex Tube | - | |
| Company | VBMScalpelCric,Cricothyrotomy Set(New Device) | CookIncorporatedMelker CuffedEmergencyCricothyrotomyCatheter Set –Surgical(PredicateDevice) | Covidien IIcAirwayConnector withFlex Tube(ReferenceDevice) | Result | |
| Regulation Number | 868.5090868.5800868.5800 | 868.5090868.5800868.5800 | 868.5810 | SubstantiallyEquivalent(A) | |
| Class | 2 | 2 | 1 | SubstantiallyEquivalent(A) | |
| Code | BWCOGPJOH | BWCOGPJOH | BZA | SubstantiallyEquivalent(A) | |
| 510(k) number | --- | K160200 | K942392 | ||
| Tube /AirwayCatheter | InnerDiameter6 mm | 5 mm | N.A. | SubstantiallyEquivalent(A) | |
| Tube /AirwayCatheter | OuterDiameter9 mm | 22 French (7,2mm) | N.A. | SubstantiallyEquivalent(A) | |
| Tube /AirwayCatheter | Length10cm | 9 cm | N.A. | SubstantiallyEquivalent(A) | |
| Bougie/Loadingdilator | OuterDiameter14 French | 14 French | N.A. | SubstantiallyEquivalent | |
| Bougie/Loadingdilator | Length40 cm | 11 cm | N.A. | SubstantiallyEquivalent(A) | |
| Bougie/Loadingdilator | Tip ShapeBlunt | Blunt | N.A. | SubstantiallyEquivalent | |
| Syringe | Volume10 ml | 6 ml | N.A. | SubstantiallyEquivalent(A) | |
| Scalpel | Type#10 | #11 | N.A. | SubstantiallyEquivalent(A) | |
| Necktape | AvailabilityIncluded | no Necktapeincluded | N.A. | SubstantiallyEquivalent(A) | |
| ExtensionTube withSwivelConnector | InnerDiameter -patientside15 mm | 15 mm | SubstantiallyEquivalent | ||
| ExtensionTube withSwivelConnector | InnerDiameter -machineside22 mm | no Extension Tubeincluded | 22 mm | SubstantiallyEquivalent | |
| ExtensionTube withSwivelConnector | Lengthextensiontube13 cm | 13 cm | SubstantiallyEquivalent |
8.1 Device Characteristics Table
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VBM Medizintechnik GmbH
ScalpelCric, Cricothyrotomy Set 510(k) Premarket Notification
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A. Differences in relevant characteristics have been separately evaluated during Substantial equivalence discussion. They do not raise new questions regarding safety and efficacy.
8.2 Summary of Technological Characteristics
The proposed devices are substantially equivalent in terms of design, operating principles and intended use and have similar technological characteristics to the predicate devices.
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の Performance Data
9.1 Sterilization and Shelf Life
ScalpelCric Set is supplied in sterile condition. EO-sterilizations is used for the sterilization of the ScalpelCric Set. ScalpelCric Set has a shelf life of 5 years.
9.2 Biocompatibility
Devices of the ScalpelCric Set were evaluated for their biological safety according to ISO 10993-1. All relevant endpoints have been considered. Tests regarding cytotoxicity, irritation, sensitization, Pyrogen, material mediated pyrogenicity and acute systemic toxicity were performed during the biological safety evaluation. All conducted tests have been successful. The evaluation shows the biological safety of the ScalpelCric Set.
| Component | Type of physical Contact | Duration of Contact | |
|---|---|---|---|
| Category | Contact | ||
| Scalpel | External Communicatingdevice | Tissue/ Bone/ Dentine | < 24 hours |
| Bougie | External Communicatingdevice | Tissue/ Bone/ Dentine | < 24 hours |
| Cuffed Tube | External Communicatingdevice | Tissue/ Bone/ Dentine | < 24 hours |
| Extension Tube | Surface device | Mucosal membrane | < 24 hours |
| Neck tape | Surface device | Intact Skin | < 24 hours |
| Syringe | Without Patient Contact | Without PatientContact | N. A. |
9.2.1 Patient Contacting Components
9.2.2 Biocompatibility tests
| Tested component | Conducted Test | Result |
|---|---|---|
| Scalpel | Cytotoxicity | Non-cytotoxic |
| Scalpel | Material Mediated Pyrogenicity | No traces of material mediatedpyrogenicity |
| Scalpel | Acute Systemic Toxicity | No acute systemic toxiccharacteristics |
| Scalpel | Pyrogen | Endotoxin free |
| Bougie | Irritation | No intracutaneous reactivity |
| Bougie | Sensitization | Non-sensitizer |
| Bougie | Cytotoxicity | Non-cytotoxic |
| Bougie | Material Mediated Pyrogenicity | No traces of material mediatedpyrogenicity |
| Bougie | Acute Systemic Toxicity | No acute systemic toxiccharacteristics |
| Cuffed Tube | Cytotoxicity | Non-cytotoxic |
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| Material Mediated Pyrogenicity | No traces of material mediated pyrogenicity | |
|---|---|---|
| Acute Systemic Toxicity | No acute systemic toxic characteristics | |
| Sensitization | Non-sensitizer | |
| Irritation | No intracutaneous reactivity | |
| Pyrogen | Endotoxin free | |
| Extension Tube | Cytotoxicity | Non-cytotoxic |
| Irritation | No intracutaneous reactivity | |
| Sensitization | Non-sensitizer | |
| Pyrogen | Endotoxin free | |
| Material Mediated Pyrogenicity | No traces of material mediated pyrogenicity | |
| Acute Systemic Toxicity | No acute systemic toxic characteristics | |
| Neck Tape | Cytotoxicity | Non-cytotoxic |
| Syringe | N.A. | N.A. |
9.3 Sterilization and Shelf Life
ScalpelCric is supplied in sterile condition and intended to be single-use. Validated EOsterilization procedure is used for sterilization. Residuals do not exceed the maximum amount defined by ISO 10993-7. The maximum shelf life of the Set is 5 years.
9.4 Bench Testing
The components of the ScalpelCric Set are extensively tested to prove the fulfillment of requirements defined during development. Tests could verify the suitability of all tested features.
| Object under Test | Features to be tested | Result |
|---|---|---|
| Bonding Connector | Bonding between connector and tube | Passed |
| Bonding Inflation Line | Bonding between inflation line andtube | Passed |
| 15mm Connector | Dimensions of 15mm Connector | Passed |
| Luer Pilot Balloon | Dimensions of the female luerconnector in the pilot balloon | Passed |
| Cuff | Function of the Cuff | Passed |
| Scalpel | Function and design of the scalpel | Passed |
| Bougie | Bougie which shall fulfill all relevantspecification according [DI] and[MS_Bougie]. | Passed |
| Tube | Function and dimensions of the tube | Passed |
| Tube | Tube is recognizable in X-Ray images | Passed |
| extension Tube | Function and dimension of theextension tube | Passed |
| Neck Tape | Neck tape which shall fulfill allrelevant specification according [DI] | Passed |
| and [MS_NT] after 4 timessterilization | ||
| Syringe | Function of the syringe | Passed |
| Tube with inflation line and cuff, | Function and features of the tube withattached inflation line and pilotballoon and with cuff | Passed |
| ScalpelCric | Biological compatibility | Passed |
| Material | Function and ingredient of theScalpelCric materials | Passed |
| Tube and extension Tube | Oxygen resistance of Tube andExtension tube | Passed |
| Label | Device Label | Passed |
| Bougie | Device Label Bougie | Passed |
| IFU | IFU which shall contain all relevantinformation regarding [DI] and [ER]. | Passed |
| ScalpelCric | ScalpelCric Set can be used inOperating condition | Passed |
| ScalpelCric | Functionality after simulated transport | Passed |
| Transport Validation | Functionality after simulated transport | Passed |
| Safety | Verify implementation andeffectiveness of all Risk ControlMeasures defined in the Risk Analysis | Passed |
| Suction Cap | Connecting tube with open suction capduring ventilation | Passed |
| User Needs | User Needs for ScalpelCric, defined in[SoP] | Passed |
| ScalpelCric | Usability | Passed |
| Headerbag | Requirements of DIN EN ISO 11607-1and DIN EN ISO 11607-2. | Passed |
| Sterilization | Sterilization Requirements forScalpelCric | Passed |
| Business Needs | Business Needs for ScalpelCric | Passed |
| Label Sterile Packaging | Sterile packaging label which shallcontain all relevant informationregarding the [SFL], [DI] and [ER]. | Passed |
| Label Outer Packaging | Outer packaging label which shallcontain all relevant informationregarding the [SFL], [DL] and [ER] | Passed |
| Packaging | Packaging Requirements forScalpelCric | Passed |
| Accelerated Aging Syringe | Quality of the syringe after 5 yearsaccelerated aging | Passed |
| Accelerated aging of Pouch | Function of the sterile packaging after5 years accelerated aging | Passed |
| Bougie | Bougie shall fulfill all relevantspecifications after 1 year acceleratedaging | Passed |
| Scalpel | Function of the scalpel afteraccelerated aging 1 year | Passed |
| ScalpelCric | Scalpel Cric Set application oxygenresistance after 1 year acceleratedaging | Passed |
| Surgicric | Function and dimension after 5 yearsaccelerated aging of the Surgicric andthe function of the sterile packaging. | Passed |
| Surgicric | are identical to the devices inScalpelCric. | Passed |
| Surgicric | Function and dimension after 3 yearsreal time aging of the Surgicricincluding Tubus and the function ofthe sterile packaging. The tested tubeand sterile packaging are identical tothe devices in ScalpelCric. | Passed |
| Syringe | Quality of the syringe after 3 yearsreal time aging | Passed |
| Bougie | Bougie shall fulfill all relevantspecifications after 5 yearsaccelerated aging | Passed |
| Scalpel | Function of the scalpel after 5 yearsaccelerated aging | Passed |
| ScalpelCric Set | Application oxygen resistance after 5years accelerated aging | Passed |
| Cuff Tube Collapse included in theScalpelCric after 5 years ofaccelerated aging. | Test required by DIN EN ISO5361:2013-03, Annex C: Resistanceof the VBM tracheal tube ventilationlumen collapse with cuff inflated insidea cylinder. | Passed |
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VBM Medizintechnik GmbH ScalpelCric, Cricothyrotomy Set 510(k) Premarket Notification
Image /page/11/Picture/1 description: The image shows the logo for VBM in a bright blue color. The letters are large and bold, taking up most of the frame. The background is white, which makes the blue letters stand out. The logo is simple and modern.
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10 Substantial Equivalence Summary / Conclusion
Based on available 510(k) information herein provided, ScalpelCric, CricothyrotomySet is considered substantially equivalent to the predicate device "Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical" in terms of intended use, technology and performance specifications.
The VBM component "Extension Tube with Swivel Connector" has been compared separately to the reference device "Airway Connector with Flex Tube". The substantially equivalence has been demonstrated in terms of clinical and biological characteristics as well as technical features.
The subject device and the predicate device have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness.
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).