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.

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.

AI/ML Overview

When analyzing the provided text for acceptance criteria and a study proving device performance, it's important to note that this FDA 510(k) clearance document is for a Class I medical device (a reservoir bag with a modification), not typically a device that requires extensive clinical studies with human participants to demonstrate performance or to assess diagnostic accuracy in the way that, for example, an AI-powered diagnostic imaging device would.

The "performance data" discussed here focuses on engineering, biocompatibility, and regulatory compliance rather than diagnostic performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, and training data will not be present in this document, as they are not applicable to the type of device and regulatory pathway involved.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct table of acceptance criteria with corresponding performance numbers in the way one might expect for a diagnostic AI device. Instead, it describes general compliance and testing outcomes.

Acceptance Criteria Category	Reported Device Performance (as inferred from the text)
Shelf-Life	Device is non-sterile and has no restriction on shelf-life.
Biocompatibility	Successfully passed testing per FDA guidance (ISO 10993-1, June 16, 2016) for: - Cytotoxicity - Sensitization - Irritation - Acute Toxicity - Pyrogenicity
Risk Management	All identified risks were reduced to acceptable levels by mitigation (design, labels, biocompatibility). All residual risks post-mitigation were deemed acceptable.
Standard Compliance	Confirmed compliance with: - ISO 5362 (Anesthetic Reservoir bags) - ISO 5356-1 (Anesthetic and respiratory equipment – conical connectors – Part 1: Cones and Sockets). This includes requirements for connectivity, capacity, leakage, disconnection, resistance to pressure, and design.
Verification Testing	All requirements (other than those addressed by standardized testing) were confirmed against specifications, labeling, and instructional requirements via a pre-approved protocol.
Overall 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..."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in terms of clinical study sample size. The tests appear to be laboratory and bench testing on the device prototypes/samples. No patient "test set" in the diagnostic sense is mentioned.
Data Provenance: Not applicable in the context of diagnostic data. The "data" refers to engineering test results and biocompatibility assays.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device does not generate diagnostic outputs requiring expert interpretation for ground truth. The "ground truth" here is compliance with engineering standards and safety/biocompatibility profiles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There are no diagnostic interpretations to adjudicate.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/diagnostic device, and no MRMC study was performed or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. Not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is adherence to established international standards (ISO 5362, ISO 5356-1) and FDA guidance for biocompatibility (ISO 10993-1), along with internal design specifications. There is no clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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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

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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

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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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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.

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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

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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 deviceexceeds the limitationsto the exemption in 21CFR 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 GenericName	Breathing bag	Breathing bag	Same
Intended use	Regulation IntendedUse	for use in a breathing circuit as areservoir for breathing gas andto assist, control, or monitor apatient's ventilation.	for use in a breathingcircuit as a reservoir forbreathing gas and to assist,control, or monitor apatient's ventilation.	Same
	Indications	The pediatric device forinduction of anesthesia (PeDIA)is an alternative to a face maskfor the inhalation induction ofanesthesia, and is intended forthe delivery of nitrous and/oranesthetic gases to children agethree years and older. It isintended to be used prior to IVinsertion, LMA/endotrachealintubation, and/or conversion toa standard mask induction.	Predicate device IntendedUse is not included withinthe labeling, which impliesit is consistent with theregulation intended use.	Equivalent. The PeDIAdevice falls within theregulation intended useand the predicateintended use.
	Pediatric Use	Exclusively pediatric	Pediatric and adult versionsavailable	Equivalent.
TechnologicalCharacteristics	Materials	Neoprene (bag)TPO (bushing)PVCAdhesiveABS	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 throughgas inhalation to airway tissues.	indirect contact throughgas inhalation to airwaytissues	Equivalent.
Contact Type	External communicating device -tissues, indirect	External communicatingdevice -tissues, indirect	Same.
Contact duration	Limited ≤ 24 hours	Limited ≤ 24 hours	Same.
Components	Breathing BagConnectorTapeAdhesivewhistle	Breathing bagConnectorTape	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

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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

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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.

Regulation Number and Section

§ 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.