The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.

Device Description

AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.

Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.

AI/ML Overview

The provided text is a 510(k) premarket notification FDA review letter for the "AllPEP" device, classified as an Incentive Spirometer. It addresses the substantial equivalence of the AllPEP device to a predicate device, DHD Acapella K991561.

The document details the device's indications for use, patient population, environment of use, and a comparison of its features and performance to the predicate device. Crucially, it highlights non-clinical bench testing as the primary method to demonstrate substantial equivalence, rather than clinical studies involving human participants or MRMC studies.

Therefore, the following is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the information provided in the document.

Acceptance Criteria and Device Performance for AllPEP

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (AllPEP)	Notes on Comparison to Predicate
Bench Testing	Aging and post-aging performance	Performed, results "similar to the predicate and within pre-defined acceptance criteria."	Results similar to predicate.
	Cleaning validation	Performed, results "similar to the predicate and within pre-defined acceptance criteria."	Results similar to predicate.
	Post-cleaning performance	Performed, results "similar to the predicate and within pre-defined acceptance criteria."	Results similar to predicate.
	Transportation - shock and vibration	Performed	Not explicitly stated for predicate.
	Frequency (Hz) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm)	5lpm - 9.82; 10lpm - 9.96; 15lpm - 11.85; 20lpm - 13.01; 25lpm - 14.89; 30lpm - 16.32	Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate."
	Amplitude (cmH2O) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm)	5lpm - 3.24; 10lpm - 6.31; 15lpm - 8.31; 20lpm - 9.42; 25lpm - 9.12; 30lpm - 9.17	Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate."
	Lowest Pressure (cmH2O) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm)	5lpm - 0.50; 10lpm - 0.78; 15lpm - 2.09; 20lpm - 4.00; 25lpm - 7.26; 30lpm - 10.75	Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate."
	Highest Pressure (cmH2O) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm)	5lpm - 3.74; 10lpm - 7.10; 15lpm - 10.40; 20lpm - 13.42; 25lpm - 16.38; 30lpm - 19.92	Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate."
Biocompatibility	ISO 10993-5:2009 - Cytotoxicity	Met applicable requirements	Based on direct contact materials.
	ISO 10993-10:2010 Sensitization and Intracutaneous Reactivity	Met applicable requirements	Based on direct contact materials.
	ISO 10993-11:2017 Material-Mediated Pyrogenicity	Met applicable requirements	Based on direct contact materials.
	ISO 10993-18:2020 Chemical Characterization and Risk Assessment	Met applicable requirements	Based on direct contact materials.
	ISO 18562-2:2018 Particulate Matter testing	Met applicable requirements	Based on direct contact materials.
	ISO 18562-3:2018 Volatile Organic Compounds (VOC) with risk assessment	Met applicable requirements	Based on direct contact materials.
Other	Indications for Use	Similar to predicate, with added detail for clarity (environment/target population).	Similar, no different questions of safety/effectiveness.
	Technology and Construction	Similar principle of operation (oscillation during exhalation).	Similar, no different concerns of safety/effectiveness.
	Environment of Use	Hospital and clinical settings	Similar (predicate also includes home care, but this difference is discussed as not raising new concerns).
	Patient Population	Patients 18+ capable of 10 lpm exhalation for 3-4s.	Similar.
	Prescriptive	Yes	Similar.
	Single Patient, multi-use	Yes	Similar.
	Patient Interface	Mouthpiece	Similar.
	Basic Components	Swinging Flap valve, one-way valve, mouthpiece.	Similar (predicate uses "Rocker," but principle of oscillation is similar).
	Cleaning method	Neutral dishwashing agent	Similar (predicate cleaning instructions not provided, but similarity based on bench testing).
	Type of patient contact with materials	Externally communicating/Tissue Surface contact/mucosa, prolonged duration (>24 hours, <30 days).	Predicate "Not published"; device replacement instruction provides similarity.

Study Details:

Sample sizes used for the test set and the data provenance:
- The document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests (e.g., number of devices tested for aging, cleaning, or performance metrics).
- Data Provenance: The tests are performed by the sponsor, Enchant Tek Co. Ltd., based in Taiwan. The data provenance is from bench testing (laboratory-controlled conditions) rather than clinical data from human subjects. The document does not specify if the testing was retrospective or prospective, but bench testing is typically considered prospective for the device being submitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on bench testing and biocompatibility test results, which compare device performance to pre-defined engineering and safety standards, and to a predicate device's characteristics. There is no mention of human expert-based ground truth establishment as would be relevant for a diagnostic AI device or clinical study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human readers or "ground truth" establishment by experts is described for this type of submission. The performance is gauged against pre-defined engineering specifications and comparison to the predicate device's established characteristics.
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 a submission for a Positive Expiratory Pressure (PEP) device, which is a mechanical therapeutic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI. It is a physical medical device. The "standalone" performance testing refers to the device's intrinsic mechanical performance (frequency, amplitude, pressure) as measured during bench tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for acceptance) for this device is established through:
  - Pre-defined engineering and performance specifications based on the device's intended function and regulatory standards for incentive spirometers.
  - Comparison to the performance characteristics of a legally marketed predicate device (DHD Acapella K991561) to establish substantial equivalence.
  - International standards (ISO 10993-series and ISO 18562-series) for biocompatibility testing.
- There is no medical "ground truth" (like disease presence from pathology or outcomes) as this is not a diagnostic device.
The sample size for the training set:
- Not applicable. This device is not an AI or machine learning product, so there is no concept of a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

Summary

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February 2, 2024

Enchant Tek Co. Ltd. Leonard Ling QA/RA Supervisor No. 210 Xiangzhong Rd. Dongshan Township Yilan County, 26950 Taiwan

Re: K233855

Trade/Device Name: AllPEP Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: December 4, 2023 Received: December 5, 2023

Dear Leonard Ling:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and

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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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Indications for Use

510(k) Number (if known) K233855

Device Name AllPEP

Indications for Use (Describe)

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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Date Prepared:	February 2, 2024
Sponsor:	Enchant Tek Co. Ltd.No. 210 Xiangzhong Rd.Dongshan Township, Yilan CountyTaipei, TW 26950Tel +886- 03-959-3500
Sponsor Contact:	Ling Leonard - QA/RA Supervisor
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	AllPEP
Common/Usual Name:	PEP device
Classification Name:	Spirometer, therapeutic (incentive)
Product Code:	21CFR 868.5690BWF
Predicate Device:	DHD Acapella K991561
Common/Usual Name:	Spirometer, therapeutic (incentive)
Classification Name:	21CFR 868.5690
Product Code:	BWF

Device Description: AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.

Indications for Use:

Patient Population:

Patients 18 years and older who are capable of generating an exhalation flow of 10 1pm for 3-4 seconds.

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Environments of use:

For hospital and clinical settings.

Substantial Equivalence Discussion

The table below compares the key features of the proposed with the identified predicate - DHD Acapella K991561. The comparison demonstrates that the subject device is substantially equivalent to the predicate device.

. Indications for Use -

The indications for use are similar for the subject device when compared to the predicate device.

Discussion - Since the predicate, newer cleared PEP devices have more details within the indications for use. We have added this information, it does not however raise different questions of safety or effectiveness.

. Technology and construction -

The technology and principle of operation is similar for the subject device when compared to the predicate device.

Discussion - While the predicate may have a different means of creating oscillation, there are a number of cleared PEP devices which also have slightly different ways of creating oscillations during the exhalation cycle. This difference does not raise different concerns of safety or effectiveness.

. Environment of Use -

The environments of use are similar to predicate which are hospital and clinical settings. Discussion - The environments of use are similar.

Patient Population -.

The patient population for the subject device is patients requiring secretion clearance and those who may have atelectasis. They should be capable of generating an exhalation flow of 10 lpm for 3-4 seconds.

Discussion - The subject and predicate device patient populations are similar.

Non-Clinical Testing Summary -

Bench testing -

The following tests were performed to demonstrate substantial equivalence:

Aging and post-aging performance ●
Cleaning validation ●
Post-cleaning performance
Frequency (Hz)
Amplitude (cmH20) ●
Pressure at min / max settings (cmH20) 0

Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria.

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Biocompatibility -

According to ISO 10993-1 and the FDA Guidance related to biocompatibility from 2020, the subject device is considered:

External Communicating
Tissue Contacting
Prolonged duration of use (>24 hours, <30 days) o

For those materials in direct contact, they would be considered:

Surface Device
Mucosal Membrane ●
o Prolonged duration of use (>24 hours, <30 days)

Based upon ISO 10993-1, the sponsor has performed the following biocompatibility tests for the subject device:

ISO 10993-5:2009 - Cytotoxicity
ISO 10993-10:2010 Sensitization and Intracutaneous Reactivity ●
ISO 10993-11:2017 Material-Mediated Pyrogenicity ●
ISO 10993-18:2020 Chemical Characterization and Risk Assessment ●
ISO 18562-2:2018 Particulate Matter testing ●
ISO 18562-3:2018 Volatile Organic Compounds (VOC) with risk assessment ●

Discussion - The subject device was found to meet the applicable requirements for biocompatibility safety for the intended population.

Discussion of Differences

There are no significant differences in indications for use, population, use environments, technological characteristics or performance which raise different concerns of safety compared to the predicate and thus should be found to be substantially equivalent.

Substantial Equivalence Conclusion

Through performance testing, design, and non-clinical testing the proposed device and predicate have been found to be substantially equivalent.

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	Subject Device	Predicate Device	Subject and Predicate Comparison
Company	Enchant Tek Co., Ltd.	DHD Acapella
510(k)	K230622	K991561
Classification No. &Product code	868.5690BWF - spirometer, therapeutic (incentive)	868.5690BWF - spirometer, therapeutic (incentive)	Identical
Indications for Use	The Enchant AllPEP is intended for use as aPositive Expiratory Pressure (PEP) bypatients 18 years and older. Patients must becapable of generating an exhalation flow of10 lpm for 3-4 seconds to promote secretionclearance. This device may be used toprevent or reverse atelectasis and as aninspiratory, deep breathing positiveexerciser. It may be used in hospital andclinical settings.	Indicated for use as a Positive ExpiratoryPressure (PEP) Deviceimproves clearance of secretionsmay reduce the need for postural drainagefacilitates opening of airways in patientswith Cystic Fibrosis, COPD, asthma, andlung diseases with secretory problemsmay be used to prevent or reverseatelectasis	SimilarMore recent PEP clearances haveincluded the environment of use andtarget population in the indicationsstatement. This does not change theintended use.
Environments of Use	Hospital and clinical settings	Hospital, clinical and home care settings	Similar, but not for home use
Prescriptive	Yes	Yes	Similar
Patient Population	Patients requiring PEP therapy aged 18years and older.Patient capable of generating an exhalationflow of 10 lpm for 3-4 seconds	Patients requiring PEP therapy	Similar
Single Patient, multi-use	Yes	Yes	Similar
Patient Interface	Mouthpiece	Mouthpiece	Similar
Basic Components	Swinging Flap valve which generatesoscillation during exhalationOne-way valve for inhalationMouthpiece	Rocker which generates oscillation duringexhalationOne-way valve for inhalationMouthpiece	SimilarThe principle of operation is theoscillation during airflow. This is similarto the predicate device and does not raisedifferent questions of safety andeffectiveness
Mean frequency range(Hz)	5lpm - 9.8210lpm - 9.9615lpm - 11.8520lpm - 13.0125lpm - 14.8930lpm - 16.32	Not published	Similar based on bench testing of subjectdevice and predicate
	Subject Device	Predicate Device	Subject and Predicate Comparison
Mean amplitudePressure (cmH20)	5lpm - 3.2410lpm - 6.3115lpm - 8.3120lpm - 9.4225lpm - 9.1230lpm - 9.17	Not published	Similar based on bench testing of subjectdevice and predicate
Lowest Pressure (cmH20)	5lpm - 0.5010lpm - 0.7815lpm - 2.0920lpm - 4.0025lpm - 7.2630lpm - 10.75	Not published	Similar based on bench testing of subjectdevice and predicate
Highest Pressure(cmH20)	5lpm - 3.7410lpm - 7.1015lpm - 10.4020lpm - 13.4225lpm - 16.3830lpm - 19.92	Not published	Similar based on bench testing of subjectdevice and predicate
Cleaning method	Neutral dishwashing agentSingle patient, multi-use	Cleaning instructions not providedSingle patient, multi-use	Similar based on bench testing of subjectdevice and predicate
Performance testing	Aging and post-aging performanceCleaning and post-cleaningperformanceCleaning validationTransportation - shock and vibrationFrequency (Hz)Amplitude (cmH2O)Pressure at min / max settings (cmH2O)	Frequency (Hz)Amplitude (cmH2O)Pressure at min I max settings (cmH2O)	Similar
Type of patient contactwith materials	Externally communicating/Tissue Surfacecontact /mucosaProlonged duration (>24 hours, < 30 days)	Not published	Patients are instructed to replace deviceevery 30 days.

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Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).