(277 days)
No
The device description and performance studies focus on the mechanical components and functionality of a surgical cricothyrotomy set, with no mention of AI or ML.
Yes
This device is intended for emergency airway access to alleviate life-threatening dyspnoea, thereby treating a pathological condition.
No
The device is described as a "Surgical Cricothyrotomy set for securing the airway," and its intended use is for "Emergency airway access." There is no mention of it being used for diagnosis or assessment of a medical condition; its function is interventional.
No
The device description explicitly lists multiple physical components (scalpel, bougie, tube, extension tube, syringe, necktape) and the performance studies focus on the physical properties and functionality of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The described device is a surgical set used to create an emergency airway directly in the patient's body by accessing the cricothyroid membrane. It is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device used for a surgical procedure to manage a life-threatening condition, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
Product codes (comma separated list FDA assigned to the subject device)
BWC, JOH, OGP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cricothyroid membrane (airway)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospital and pre-hospital conditions including military use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device underwent biocompatibility testing according to ISO 10993-1. Tests performed included cytotoxicity, irritation, sensitization, Pyrogen, material mediated pyrogenicity, and acute systemic toxicity. All tests were successful, demonstrating biological safety.
Bench testing was conducted to verify the fulfillment of defined requirements for various components of the ScalpelCric Set (e.g., bonding, dimensions, cuff function, scalpel function, bougie specifications, tube function/dimensions, extension tube function/dimensions, neck tape specifications, syringe function, biological compatibility, material function/ingredients, oxygen resistance, labeling, IFU, operating condition suitability, simulated transport functionality, risk control measures, suction cap connection, user needs, usability, sterile packaging requirements, sterilization requirements, business needs, and accelerated/real-time aging tests for various components like syringe, pouch, bougie, scalpel, and Surgicric components). All tested features passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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.
3
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K200190
VOLUME 003
510(k) Summary
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| DATE OF APPLICATION: | 10/26/2020 |
|---|---|
| APPLICANT: | VBM Medizintechnik GmbH |
| Einsteinstrasse 1 | |
| 72172 Sulz a. N. | |
| Germany | |
| Tel: + 49 (0) 7454 9596 0 | |
| Fax: +49 (0) 7454 9596 33 | |
| E-Mail: info@vbm-medical.de | |
| CONTACT PERSON: | Jannika Jaeger |
| Regulatory Affairs Manager | |
| Tel.: + 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 Set |
| Needle, Emergency Airway | |
| Device Classification Name: | Cricothyrotomy Kit |
| 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
Description | Regulation
Medical
Specialty | Review Panel | Product
Code | Regulation
Number | Device
Classificatio
n |
|--------------------------------|--------------------------------|------------------------------------|----------------|-----------------|----------------------|------------------------------|
| Needle,
Emergency
Airway | Emergency
airway
needle. | Anesthesiology | Anesthesiology | BWC | 868.5090 | 2 |
Additional Product ode
| Device | Regulation
Description | Regulation
Medical
Specialty | Review Panel | Product
Code | Regulation
Number | Device
Classificatio
n |
|---------------------------------------|-----------------------------------------|------------------------------------|----------------|-----------------|----------------------|------------------------------|
| Tube
tracheostomy
and tube cuff | Tracheostom
y tube and
tube cuff. | Anesthesiology | Anesthesiology | JOH | 868.5800 | 2 |
Predicate Device / Reference Device ന
| Device | Predicate Device | Reference
Device | 510(k)
Number | 510(k) Holder |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------|----------------------------------------------------------------------------------|
| Needle, Emergency
Airway | Melker Cuffed Emergency
Cricothyrotomy Catheter
Set -Percutaneous, Melker
Cuffed Emergency
Cricothyrotomy Catheter
Set - Surgical, Melker
Universal Cuffed
Emergency Cricothyrotomy
Catheter Set | --- | K160200 | COOK
INCORPORATED
750 DANIELS WAY
Bloomington,
Indiana 47404 |
| | --- | Airway
Connector
with Flex Tube | K942392 | Covidien Llc
formerly
MALLINCKRODT
DAR S.R.L.
15 HAMPSHIRE
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
ScalpelCric,
Cricothyrotomy Set
(New Device) | Cook
Incorporated
Melker Cuffed
Emergency
Cricothyrotomy
Catheter Set -
Surgical
(Predicate
Device) | Covidien IIc
Airway
Connector with
Flex Tube
(Reference
Device) | Result | |
|-------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------|
| Device Name | Needle, Emergency
Airway
Cricothyrotomy kit
Tube tracheostomy and
tube cuff | Needle, Emergency
Airway
Cricothyrotomy kit
Tube tracheostomy
and tube cuff | Airway Connector
with Flex Tube | - | |
| | Company | VBM
ScalpelCric,
Cricothyrotomy Set
(New Device) | Cook
Incorporated
Melker Cuffed
Emergency
Cricothyrotomy
Catheter Set –
Surgical
(Predicate
Device) | Covidien IIc
Airway
Connector with
Flex Tube
(Reference
Device) | Result |
| | Regulation Number | 868.5090
868.5800
868.5800 | 868.5090
868.5800
868.5800 | 868.5810 | Substantially
Equivalent(A) |
| | Class | 2 | 2 | 1 | Substantially
Equivalent(A) |
| | Code | BWC
OGP
JOH | BWC
OGP
JOH | BZA | Substantially
Equivalent(A) |
| | 510(k) number | --- | K160200 | K942392 | |
| | Tube /
Airway
Catheter | Inner
Diameter
6 mm | 5 mm | N.A. | Substantially
Equivalent(A) |
| | Tube /
Airway
Catheter | Outer
Diameter
9 mm | 22 French (7,2
mm) | N.A. | Substantially
Equivalent(A) |
| | Tube /
Airway
Catheter | Length
10cm | 9 cm | N.A. | Substantially
Equivalent(A) |
| | Bougie
/Loading
dilator | Outer
Diameter
14 French | 14 French | N.A. | Substantially
Equivalent |
| | Bougie
/Loading
dilator | Length
40 cm | 11 cm | N.A. | Substantially
Equivalent(A) |
| | Bougie
/Loading
dilator | Tip Shape
Blunt | Blunt | N.A. | Substantially
Equivalent |
| | Syringe | Volume
10 ml | 6 ml | N.A. | Substantially
Equivalent(A) |
| | Scalpel | Type
#10 | #11 | N.A. | Substantially
Equivalent(A) |
| | Necktape | Availability
Included | no Necktape
included | N.A. | Substantially
Equivalent(A) |
| | Extension
Tube with
Swivel
Connecto
r | Inner
Diameter -
patient
side
15 mm | 15 mm | | Substantially
Equivalent |
| | Extension
Tube with
Swivel
Connecto
r | Inner
Diameter -
machine
side
22 mm | no Extension Tube
included | 22 mm | Substantially
Equivalent |
| | Extension
Tube with
Swivel
Connecto
r | Length
extension
tube
13 cm | | 13 cm | Substantially
Equivalent |
8.1 Device Characteristics Table
8
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 | ||
| device | Tissue/ Bone/ Dentine |