ScalpelCric

K200190 · VBM Medizintechnik GmbH · BWC · Oct 30, 2020 · Anesthesiology

Device Facts

• Record ID: K200190
• Device Name: ScalpelCric
• Applicant: VBM Medizintechnik GmbH
• Product Code: BWC · Anesthesiology
• Decision Date: Oct 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5090
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Surgical cricothyrotomy set for emergency airway access; used in hospital and pre-hospital settings (including military) by clinicians. Components include scalpel, bougie, cuffed tube, extension tube with swivel connector, syringe, and necktape. Procedure: incision of cricothyroid membrane; bougie insertion; tube placement over bougie into trachea; bougie removal; cuff inflation; tube fixation. Enables ventilation via resuscitation bags or standard systems. Benefits: provides life-saving airway access when other ventilation attempts fail.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified bonding, dimensions, cuff function, X-ray visibility, oxygen resistance, and functionality after simulated transport and accelerated aging (up to 5 years). Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, irritation, sensitization, pyrogenicity, acute systemic toxicity).

Technological Characteristics

Single-use surgical cricothyrotomy kit. Components: scalpel, bougie (14 Fr), cuffed tube (6mm ID/9mm OD), extension tube with swivel connector, syringe (10ml), necktape. Materials evaluated for biocompatibility per ISO 10993. Sterilization: Ethylene Oxide (EO). Shelf life: 5 years. Mechanical assembly; no electronic or software components.

Indications for Use

Indicated for emergency airway access via the cricothyroid membrane in adults experiencing life-threatening dyspnoea that cannot be controlled in any other way.

Regulatory Classification

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.

Predicate Devices

• Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical (K160200)

Reference Devices

• Airway Connector with Flex Tube (K942392)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 GmbH<br>Einsteinstrasse 1<br>72172 Sulz a. N.<br>Germany<br>Tel: + 49 (0) 7454 9596 0<br>Fax: [phone]<br>E-Mail: [e-mail] |
| CONTACT PERSON: | Jannika Jaeger<br>Regulatory Affairs Manager<br>Tel.: + 49 (0) 7454 9596 660 |

E-Mail: [e-mail]

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#### 1 Device Name

| Trade Name: | ScalpelCric |
|-----------------------------|-------------------------------------------------------|
| Common Name: | Cricothyrotomy Set<br>Needle, Emergency Airway |
| Device Classification Name: | Cricothyrotomy Kit<br>Tube tracheostomy and tube cuff |

# 2 Classification / Product Code

ScalpelCric can be classified according to following device name and product code:

Primary Product Code

| Device | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review Panel | Product<br>Code | Regulation<br>Number | Device<br>Classificatio<br>n |
|--------------------------------|--------------------------------|------------------------------------|----------------|-----------------|----------------------|------------------------------|
| Needle,<br>Emergency<br>Airway | Emergency<br>airway<br>needle. | Anesthesiology | Anesthesiology | BWC | 868.5090 | 2 |

### Additional Product ode

| Device | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review Panel | Product<br>Code | Regulation<br>Number | Device<br>Classificatio<br>n |
|---------------------------------------|-----------------------------------------|------------------------------------|----------------|-----------------|----------------------|------------------------------|
| Tube<br>tracheostomy<br>and tube cuff | Tracheostom<br>y tube and<br>tube cuff. | Anesthesiology | Anesthesiology | JOH | 868.5800 | 2 |

#### Predicate Device / Reference Device ന

| Device | Predicate Device | Reference<br>Device | 510(k)<br>Number | 510(k) Holder |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------|----------------------------------------------------------------------------------|
| Needle, Emergency<br>Airway | Melker Cuffed Emergency<br>Cricothyrotomy Catheter<br>Set -Percutaneous, Melker<br>Cuffed Emergency<br>Cricothyrotomy Catheter<br>Set - Surgical, Melker<br>Universal Cuffed<br>Emergency Cricothyrotomy<br>Catheter Set | --- | K160200 | COOK<br>INCORPORATED<br>750 DANIELS WAY<br>Bloomington,<br>Indiana 47404 |
| | --- | Airway<br>Connector<br>with Flex Tube | K942392 | Covidien Llc<br>formerly<br>MALLINCKRODT<br>DAR S.R.L.<br>15 HAMPSHIRE<br>STREET |

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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<br>---<br>ScalpelCric,<br>Cricothyrotomy Set<br>(New Device) | Cook<br>Incorporated<br>---<br>Melker Cuffed<br>Emergency<br>Cricothyrotomy<br>Catheter Set -<br>Surgical<br>(Predicate<br>Device) | Covidien IIc<br>---<br>Airway<br>Connector with<br>Flex Tube<br>(Reference<br>Device) | Result | |
|-------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------|
| Device Name | Needle, Emergency<br>Airway<br>Cricothyrotomy kit<br>Tube tracheostomy and<br>tube cuff | Needle, Emergency<br>Airway<br>Cricothyrotomy kit<br>Tube tracheostomy<br>and tube cuff | Airway Connector<br>with Flex Tube | - | |
| | Company | VBM<br>ScalpelCric,<br>Cricothyrotomy Set<br>(New Device) | Cook<br>Incorporated<br>Melker Cuffed<br>Emergency<br>Cricothyrotomy<br>Catheter Set –<br>Surgical<br>(Predicate<br>Device) | Covidien IIc<br>Airway<br>Connector with<br>Flex Tube<br>(Reference<br>Device) | Result |
| | Regulation Number | 868.5090<br>868.5800<br>868.5800 | 868.5090<br>868.5800<br>868.5800 | 868.5810 | Substantially<br>Equivalent(A) |
| | Class | 2 | 2 | 1 | Substantially<br>Equivalent(A) |
| | Code | BWC<br>OGP<br>JOH | BWC<br>OGP<br>JOH | BZA | Substantially<br>Equivalent(A) |
| | 510(k) number | --- | K160200 | K942392 | |
| | Tube /<br>Airway<br>Catheter | Inner<br>Diameter<br>6 mm | 5 mm | N.A. | Substantially<br>Equivalent(A) |
| | Tube /<br>Airway<br>Catheter | Outer<br>Diameter<br>9 mm | 22 French (7,2<br>mm) | N.A. | Substantially<br>Equivalent(A) |
| | Tube /<br>Airway<br>Catheter | Length<br>10cm | 9 cm | N.A. | Substantially<br>Equivalent(A) |
| | Bougie<br>/Loading<br>dilator | Outer<br>Diameter<br>14 French | 14 French | N.A. | Substantially<br>Equivalent |
| | Bougie<br>/Loading<br>dilator | Length<br>40 cm | 11 cm | N.A. | Substantially<br>Equivalent(A) |
| | Bougie<br>/Loading<br>dilator | Tip Shape<br>Blunt | Blunt | N.A. | Substantially<br>Equivalent |
| | Syringe | Volume<br>10 ml | 6 ml | N.A. | Substantially<br>Equivalent(A) |
| | Scalpel | Type<br>#10 | #11 | N.A. | Substantially<br>Equivalent(A) |
| | Necktape | Availability<br>Included | no Necktape<br>included | N.A. | Substantially<br>Equivalent(A) |
| | Extension<br>Tube with<br>Swivel<br>Connecto<br>r | Inner<br>Diameter -<br>patient<br>side<br>15 mm | 15 mm | | Substantially<br>Equivalent |
| | Extension<br>Tube with<br>Swivel<br>Connecto<br>r | Inner<br>Diameter -<br>machine<br>side<br>22 mm | no Extension Tube<br>included | 22 mm | Substantially<br>Equivalent |
| | Extension<br>Tube with<br>Swivel<br>Connecto<br>r | Length<br>extension<br>tube<br>13 cm | | 13 cm | Substantially<br>Equivalent |

### 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 Communicating<br>device | Tissue/ Bone/ Dentine | < 24 hours |
| Bougie | External Communicating<br>device | Tissue/ Bone/ Dentine | < 24 hours |
| Cuffed Tube | External Communicating<br>device | 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 Patient<br>Contact | 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 mediated<br>pyrogenicity |
| Scalpel | Acute Systemic Toxicity | No acute systemic toxic<br>characteristics |
| 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 mediated<br>pyrogenicity |
| Bougie | Acute Systemic Toxicity | No acute systemic toxic<br>characteristics |
| 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 and<br>tube | Passed |
| 15mm Connector | Dimensions of 15mm Connector | Passed |
| Luer Pilot Balloon | Dimensions of the female luer<br>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<br>specification according [DI] and<br>[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<br>extension tube | Passed |
| Neck Tape | Neck tape which shall fulfill all<br>relevant specification according [DI] | Passed |
| | and [MS_NT] after 4 times<br>sterilization | |
| Syringe | Function of the syringe | Passed |
| Tube with inflation line and cuff, | Function and features of the tube with<br>attached inflation line and pilot<br>balloon and with cuff | Passed |
| ScalpelCric | Biological compatibility | Passed |
| Material | Function and ingredient of the<br>ScalpelCric materials | Passed |
| Tube and extension Tube | Oxygen resistance of Tube and<br>Extension tube | Passed |
| Label | Device Label | Passed |
| Bougie | Device Label Bougie | Passed |
| IFU | IFU which shall contain all relevant<br>information regarding [DI] and [ER]. | Passed |
| ScalpelCric | ScalpelCric Set can be used in<br>Operating condition | Passed |
| ScalpelCric | Functionality after simulated transport | Passed |
| Transport Validation | Functionality after simulated transport | Passed |
| Safety | Verify implementation and<br>effectiveness of all Risk Control<br>Measures defined in the Risk Analysis | Passed |
| Suction Cap | Connecting tube with open suction cap<br>during ventilation | Passed |
| User Needs | User Needs for ScalpelCric, defined in<br>[SoP] | Passed |
| ScalpelCric | Usability | Passed |
| Headerbag | Requirements of DIN EN ISO 11607-1<br>and DIN EN ISO 11607-2. | Passed |
| Sterilization | Sterilization Requirements for<br>ScalpelCric | Passed |
| Business Needs | Business Needs for ScalpelCric | Passed |
| Label Sterile Packaging | Sterile packaging label which shall<br>contain all relevant information<br>regarding the [SFL], [DI] and [ER]. | Passed |
| Label Outer Packaging | Outer packaging label which shall<br>contain all relevant information<br>regarding the [SFL], [DL] and [ER] | Passed |
| Packaging | Packaging Requirements for<br>ScalpelCric | Passed |
| Accelerated Aging Syringe | Quality of the syringe after 5 years<br>accelerated aging | Passed |
| Accelerated aging of Pouch | Function of the sterile packaging after<br>5 years accelerated aging | Passed |
| Bougie | Bougie shall fulfill all relevant<br>specifications after 1 year accelerated<br>aging | Passed |
| Scalpel | Function of the scalpel after<br>accelerated aging 1 year | Passed |
| ScalpelCric | Scalpel Cric Set application oxygen<br>resistance after 1 year accelerated<br>aging | Passed |
| Surgicric | Function and dimension after 5 years<br>accelerated aging of the Surgicric and<br>the function of the sterile packaging. | Passed |
| | | |
| Surgicric | are identical to the devices in<br>ScalpelCric. | Passed |
| Surgicric | Function and dimension after 3 years<br>real time aging of the Surgicric<br>including Tubus and the function of<br>the sterile packaging. The tested tube<br>and sterile packaging are identical to<br>the devices in ScalpelCric. | Passed |
| Syringe | Quality of the syringe after 3 years<br>real time aging | Passed |
| Bougie | Bougie shall fulfill all relevant<br>specifications after 5 years<br>accelerated aging | Passed |
| Scalpel | Function of the scalpel after 5 years<br>accelerated aging | Passed |
| ScalpelCric Set | Application oxygen resistance after 5<br>years accelerated aging | Passed |
| Cuff Tube Collapse included in the<br>ScalpelCric after 5 years of<br>accelerated aging. | Test required by DIN EN ISO<br>5361:2013-03, Annex C: Resistance<br>of the VBM tracheal tube ventilation<br>lumen collapse with cuff inflated inside<br>a 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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Image /page/12/Picture/1 description: The image shows the letters VBM in a bold, sans-serif font. The letters are all capitalized and are a bright blue color. The letters are arranged horizontally, with the V on the left, the B in the middle, and the M on the right. The background is white.

# 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.