(117 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms, data sets, or performance metrics typically associated with AI/ML.
No
The device is used for the delivery of anesthetic gases to induce anesthesia, it is not used to treat or cure a disease or condition.
No
The device is described as an "alternative to a face mask for the inhalation induction of anesthesia" and is for "the delivery of nitrous and/or anesthetic gases." Its purpose is to deliver substances aiding in anesthesia, not to diagnose a condition or disease.
No
The device description clearly outlines a physical, single-use, disposable mask-free anesthetic delivery system with a balloon and whistle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- PeDIA's Function: The PeDIA device is used to deliver anesthetic gases directly to a patient's airway for the purpose of inducing anesthesia. It is a therapeutic device used on the patient, not a diagnostic device used to analyze samples from the patient.
- Intended Use: The intended use clearly states it's for the "delivery of nitrous and/or anesthetic gases to children" and is an "alternative to a face mask for the inhalation induction of anesthesia." This is a direct intervention, not a diagnostic test.
- Device Description: The description focuses on its mechanical function in delivering gas and its use in place of a standard mask. There is no mention of analyzing biological samples.
Therefore, the PeDIA device falls under the category of a therapeutic or anesthetic delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction.
Product codes (comma separated list FDA assigned to the subject device)
BTC
Device Description
The Pediatric Device for Induction of Anesthesia (PeDIA) is a single-use, disposable, mask-free anesthetic delivery system and method used for children 3 years and older. The balloon is a standard, legally marketed reservoir bag that is modified by the addition of a whistle at the opposite end of the connector (which is a closed end on standard balloons). This balloon is used in place of the initial application of anesthesia gasses. Once the child is sedated the product is removed and replaced with a standard pediatric mask for the duration of anesthesia. The proposed PeDIA device is compatible with standard anesthesia circuits, attaching in place of the mask.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth, indirect contact through gas inhalation to airway tissues.
Indicated Patient Age Range
children age three years and older.
Intended User / Care Setting
Not Found
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)
Shelf-Life testing: The device is non-sterile and there is no restriction on shelf-life.
Biocompatibility testing: The biocompatibility evaluation for the PeDIA device was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is categorized in ISO 10993-1:2009 as "External communicating device tissue/bone/dentin" per section 5.2.2(b). The device will have limited contact of less than or equal to 24 hours. Testing completed on this device includes: Cytotoxicity, Sensitization, Irritation, Acute Toxicity, Pyrogenicity.
Risk Based Approach: The Risk Management report was prepared to determine the necessary risk-mitigation measures in the design and the manufacturing of the PeDIA device. Many of the risks are mitigated by design, labels, and biocompatibility, the associated information is included in the referenced sections. Mechanical and performance testing is included in this section. The risks related to all applicable hazards which were identified for the PeDIA device have been reduced to the acceptable level by mitigation. Therefore, all residual risks post-mitigation have been deemed acceptable for this design.
Standard Compliance: Standard compliance to ISO 5362 Anesthetic Reservoir bags and ISO 5356-1, Anesthetic and respiratory equipment – conical connectors – Part 1: Cones and Sockets was confirmed by a MET Laboratories. The standard includes requirements for connectivity to adjacent anesthetic equipment, capacity, leakage, disconnection, resistance to pressure, and design requirements.
Verification: Verification testing to confirm all requirements other than those addressed by the standardized testing is completed per a preapproved protocol and includes confirmation of specification, labeling, and instructional requirements.
Conclusion: Tests were successfully performed and all acceptance criteria were met, thus confirming that the PeDIA device satisfactorily meets requirements. There were no different questions of safety and effectiveness identified during review of Risk Management documentation or execution of Validation activities.
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.
Not Found
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
§ 868.5320 Reservoir bag.
(a)
Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
PeDIA, LLC % Christina Henza Regulatory Ultra LifeScience Solutions Inc. 872 S. Milwaukee Avenue, #286 Libertyville, Illinois 60048
Re: K181424
Trade/Device Name: Pediatric Device for Induction of Anesthesia (PeDIA) Regulation Number: 21 CFR 868.5320 Regulation Name: Reservoir Bag Regulatory Class: Class I Product Code: BTC Dated: August 29, 2018 Received: August 29, 2018
Dear Christina Henza:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. Courtney -S
Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181424
Device Name
Pediatric Device for Induction of Anesthesia (PeDIA)
Indications for Use (Describe)
The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction
| 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)
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3
5 510 (k) Summary for PeDIA
Date: 9/21/2018
l. SUBMITTTER/ 510(K) HOLDER
PeDIA, LLC 3057 Nutley St Fairfax, Virginia 22031, United States
Primary Contact: Diane Miller, MHS, CRNA, CEO PeDIA, LLC Direct: 1.703.966.9578 Email: contact@pediallc.com
Submission Contact:
Christina Henza chenza@ultralifescience.com
-
II. DEVICE NAME
Pediatric Device for Induction of Anesthesia (PeDIA) Proprietary Name: Common/Usual Name: Reservoir bag Classification Name: Bag Device Class: I Panel: Anesthesiology Product Code: BTC Regulation: 868.5320 -
III. PREDICATE DEVICES
PeDIA is substantially equivalent to the existing class I King Breathing Bags (predicate device - K880680) by King Systems. The proposed PeDIA device is submitted for premarket notification [510(k) pathway] because the addition of the extra connector/mouthpiece causes the device to exceed the limitations to the exemption in 21 CFR 868.9(b) in that it introduces a different scientific technology to a reservoir bag.
4
IV. DEVICE DESCRIPTION
The Pediatric Device for Induction of Anesthesia (PeDIA) is a single-use, disposable, mask-free anesthetic delivery system and method used for children 3 years and older.
Image /page/4/Picture/3 description: The image shows a sketch of a Woulfe bottle, a type of laboratory glassware. The bottle has a bulbous body with a narrow neck at the top and a similar but shorter neck at the bottom. The sketch is done in a simple, technical style, emphasizing the shape and structure of the bottle. The bottle appears to be made of clear glass.
Mouthpiece (whistle) used by patient to inhale and exhale gases
Balloon fills with anesthetic gases
Universal connector attaches to anesthesia breathing circuit
The balloon is a standard, legally marketed reservoir bag that is modified by the addition of a whistle at the opposite end of the connector (which is a closed end on standard balloons). This balloon is used in place of the initial application of anesthesia gasses. Once the child is sedated the product is removed and replaced with a standard pediatric mask for the duration of anesthesia.
Compatible Devices
The proposed PeDIA device is compatible with standard anesthesia circuits, attaching in place of the mask.
V. INDICATIONS FOR USE
The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED TO THE PREDICATE DEVICE
| Substantial Equivalence Table | ||||
|---|---|---|---|---|
| Proposed Device | Predicate Device | Explanation of Variation | ||
| Regulatory Information | Name | PeDIA | King Systems breathing bag | N/A |
| 510(k)# | K181424 | K880680 | The proposed device | |
| exceeds the limitations | ||||
| to the exemption in 21 | ||||
| CFR 868.9(b) | ||||
| Predicate | King Systems Breathing Bag | unknown | Equivalent. | |
| Product Code | BTC | BTC | Same | |
| Class | 1 | 1 | Same | |
| Combination Product | No | No | Same | |
| Regulation Number | 868.5320 | 868.5320 | Same | |
| Regulation Generic | ||||
| Name | Breathing bag | Breathing bag | Same | |
| Intended use | Regulation Intended | |||
| Use | for use in a breathing circuit as a | |||
| reservoir for breathing gas and | ||||
| to assist, control, or monitor a | ||||
| patient's ventilation. | for use in a breathing | |||
| circuit as a reservoir for | ||||
| breathing gas and to assist, | ||||
| control, or monitor a | ||||
| patient's ventilation. | Same | |||
| Indications | The pediatric device for | |||
| induction of anesthesia (PeDIA) | ||||
| is an alternative to a face mask | ||||
| for the inhalation induction of | ||||
| anesthesia, and is intended for | ||||
| the delivery of nitrous and/or | ||||
| anesthetic gases to children age | ||||
| three years and older. It is | ||||
| intended to be used prior to IV | ||||
| insertion, LMA/endotracheal | ||||
| intubation, and/or conversion to | ||||
| a standard mask induction. | Predicate device Intended | |||
| Use is not included within | ||||
| the labeling, which implies | ||||
| it is consistent with the | ||||
| regulation intended use. | Equivalent. The PeDIA | |||
| device falls within the | ||||
| regulation intended use | ||||
| and the predicate | ||||
| intended use. | ||||
| Pediatric Use | Exclusively pediatric | Pediatric and adult versions | ||
| available | Equivalent. | |||
| Technological | ||||
| Characteristics | Materials | Neoprene (bag) | ||
| TPO (bushing) | ||||
| PVC | ||||
| Adhesive | ||||
| ABS | Neoprene (bag) | |||
| TPO (bushing) | ||||
| PVC | Equivalent. | |||
| Biocompatibility | Biocompatible | Biocompatible | Same. | |
| Substantial Equivalence Table | ||||
| Proposed Device | Predicate Device | Explanation of Variation | ||
| Anatomical sites | Mouth, indirect contact through | |||
| gas inhalation to airway tissues. | indirect contact through | |||
| gas inhalation to airway | ||||
| tissues | Equivalent. | |||
| Contact Type | External communicating device - | |||
| tissues, indirect | External communicating | |||
| device -tissues, indirect | Same. | |||
| Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same. | |
| Components | Breathing Bag | |||
| Connector | ||||
| Tape | ||||
| Adhesive | ||||
| whistle | Breathing bag | |||
| Connector | ||||
| Tape | Equivalent. | |||
| Performance | ISO 5362 & ISO 5356-1 | ISO 5362 & ISO 5356-1 | Equivalent | |
| Sterile? | Not sterile | Not sterile | Same | |
| Storage conditions | keep dry | Keep dry | Same | |
| Shelf Life | Not restricted | Not restricted | Same |
6
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Shelf-Life testing:
The device is non-sterile and there is no restriction on shelf-life
Biocompatibility testing:
The biocompatibility evaluation for the PeDIA device was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016 This device is categorized in ISO 10993-1:2009 as "External communicating device tissue/bone/dentin" per section 5.2.2(b). The device will have limited contact of less than or equal to 24 hours. Testing completed on this device includes:
- Cytotoxicity
- Sensitization
- . Irritation
- Acute Toxicity ●
- . Pyrogenicity
7
Risk Based Approach
The Risk Management report was prepared to determine the necessary risk-mitigation measures in the design and the manufacturing of the PeDIA device. Many of the risks are mitigated by design, labels, and biocompatibility, the associated information is included in the referenced sections. Mechanical and performance testing is included in this section. The risks related to all applicable hazards which were identified for the PeDIA device have been reduced to the acceptable level by mitigation. Therefore, all residual risks post-mitigation have been deemed acceptable for this design.
Standard Compliance
Standard compliance to ISO 5362 Anesthetic Reservoir bags and ISO 5356-1, Anesthetic and respiratory equipment – conical connectors – Part 1: Cones and Sockets was confirmed by a MET Laboratories. The standard includes requirements for connectivity to adjacent anesthetic equipment, capacity, leakage, disconnection, resistance to pressure, and design requirements.
Verification
Verification testing to confirm all requirements other than those addressed by the standardized testing is completed per a preapproved protocol and includes confirmation of specification, labeling, and instructional requirements.
Conclusion
Tests were successfully performed and all acceptance criteria were met, thus confirming that the PeDIA device satisfactorily meets requirements. There were no different questions of safety and effectiveness identified during review of Risk Management documentation or execution of Validation activities.
VIII. CONCLUSIONS
Based on the information and supporting documentation provided in the premarket notification, the PeDIA device is substantially equivalent to the cited predicate device. Testing demonstrates that the PeDIA device fulfills prospectively defined design and performance specifications.