This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

Device Description

The Therapy Mask 3100 NC/SP consists of a minimal contact nasal mask cushion/SP: silicone pillows cushion), a two-point headgear, and a mask frame with exhalation port. The mask frame contains enclosed magnets and connects to the nasal mask cushion (NC/SP) magnetically for easy and secure assembly/disassembly by the user. The nasal mask cushion enclosed magnets and the mask frame enclosed magnets are of opposite polarity to prevent incorrect assembly of the mask. The Therapy Mask 3100 NC/SP has a pig tail tube in front mask.

The nasal cushion seals around the bottom of the patient's nose. Nasal cushion (NC) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), and large (L). The silicone pillows cushion tips seal at the entrance to the nares and the pillows cushion base sits under the silicone pillows cushion (SP) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), large (L). The headgear has one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. The mask frame is one size and connects to the mask frame connects to the mask cushion magnetically for easy and secure assembly/disassembly by the user.

The Therapy Mask 3100 NC/SP has a 10 mm pig tail tube in front mask. The 10 mm pig tail tubing contains built-in exhalation at the top of the tube where the pig tail tubing connects to the pig tail tubing will also include an ISO 5356-1 compliant, 22 mm male conical swivel connector. The male connector will connector will connect directly to ISO 5356-1 compliant, 22 mm female connector used on therapy device tubing. The male conical swivel connector is detachable from the pig tail tubing, via a quick disconnect feature. When the male concector is detached, the pig tail tubing connects to 12 mm therapy device tubing directly.

The Therapy Mask 3100 NC/SP is designed to be easily disassembled for cleaning or replacement purposes. The components may be cleaned by the patient in the home (single patient - multiple use) or cleaned and disinfected by the professional in the hospital/institutional environment (multiple patient – multiple use).

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device (Therapy Mask 3100 NC/SP) and establishes its substantial equivalence to a predicate device. It does not present a study with acceptance criteria and device performance results in the context of an AI/ML medical device where performance metrics (e.g., sensitivity, specificity, AUC) are typically evaluated.

Instead, this document focuses on demonstrating that modifications made to an existing device (K231313) do not impact its safety and effectiveness compared to a previously cleared device (K210386). The "acceptance criteria" here implicitly refer to the continued adherence to established performance specifications and safety standards for CPAP/bi-level therapy masks.

Therefore, I cannot extract information related to:

A table of acceptance criteria vs. specific device performance metrics (like sensitivity, specificity, etc.) for AI/ML models.
Sample sizes used for a test set (in the context of AI/ML evaluation).
Number of experts for ground truth establishment.
Adjudication methods.
MRMC studies or effect sizes of human reader improvement with AI.
Standalone algorithm performance.
Type of ground truth (pathology, outcomes data).
Training set sample size or how its ground truth was established.

The document explicitly states:

"No non-clinical and/or clinical tests summaries are submitted with this CBE submission. These labeling changes do not affect the product performance related to design outputs or specifications; therefore, additional design validation of product performance requirements was not required to implement this change."

This means that the submission is primarily for labeling changes (updated contraindications and warnings regarding magnets) and a re-naming of a component, not for a new device requiring extensive performance testing against acceptance criteria in the way an AI/ML diagnostic or prognostic device would.

However, I can extract the following relevant information based on the premise of the K231313 application, which focuses on device similarity and updated labeling:

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

As explained above, this document does not present performance data in the typical sense of an AI/ML device. The "acceptance criteria" are implied by the performance of the predicate device and the claim that the current device maintains those performance characteristics. The table below outlines the comparison of key specifications between the predicate and subject devices, which serves as the basis for the "acceptance" of substantial equivalence. The "performance" is implicitly stated as "Same" across these critical parameters, indicating that the subject device performs equivalently to the predicate.

The study that proves the device meets the acceptance criteria:

The "study" in this context is the comparison between the subject device (K231313) and its predicate (K210386), as presented in the 510(k) summary. The applicant's assertion is that because the "performance and technological characteristics" of the subject device are substantially equivalent to the predicate, and the modifications (primarily labeling changes and a component re-naming) do not raise new questions of safety and effectiveness, no new non-clinical or clinical tests were required to demonstrate adherence to performance criteria.

This is a claim of substantial equivalence for a minor modification/re-submission, not a de novo performance study for a new device, especially not an AI/ML powered device.

Therefore, for your remaining points, the answer is that the document explicitly states "No non-clinical and/or clinical tests summaries are submitted with this CBE submission." This means the typical elements of an AI/ML device study are not applicable or provided here:

2. Sample sized used for the test set and the data provenance: Not applicable; no new test set was used to re-evaluate performance due to the nature of the submission (labeling changes, re-submission for an existing device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
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 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.

28 July 2023

Respironics Inc. Shipra Gulati Principal Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K231313

Trade/Device Name: Therapy Mask 3100 NC/SP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 30, 2023 Received: June 30, 2023

Dear Shipra Gulati:

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

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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 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 (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 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 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) K231313

Device Name Therapy Mask 3100 NC/SP

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 510(k) Summary Prepared	July 27, 2023
510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
Official Contact	Shipra GulatiPrincipal Regulatory Affairs EngineerP: 617.650.7502E: SRC.RA.Dept@philips.com
Establishment Registration #	2518422
Proprietary Name	Therapy Mask 3100 NC/SP
Common/Usual Name	Nasal Mask
Classification	Class II device
Classification Panel	Anesthesiology
Classification Reference	21 CFR 868.5905
Classification Name/Product Code	Ventilator, non-continuous (respirator)/BZD
Predicate Device	Therapy Mask 3100 NC/SP (K210386)

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Device Description

Indications for Use Statement

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospitalinstitutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

Subject Device Compared to the Predicate Device

The subject device, the Therapy Mask 3100 NC/SP, has the following similarities to the previously cleared predicate device, Therapy Mask 3100 NC/SP (K210386):

. Same operating principle
Same nasal mask design type ●
Same patient population ●
Same environment of use
Same patient usage type (single patient use/multi-patient use) .

Respironics, Inc. has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the Therapy Mask 3100 NC/SP device in this substantially equivalent to the predicate device.

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Comparison Table of Predicate and Subject Device

Feature /Function	Predicate Device:Magneto Nasal Mask(K210386)	Subject Device:Therapy Mask 3100 NC/SP(K231313)	Similarities and/orDifferences
Product Code	BZD	BZD	Same
Intended Use	This mask is intended to provide aninterface for application of CPAP orbi-level therapy to patients. Themask is for single patient use in thehome and multi-patient use in thehospital/institutional environment.The mask is to be used on patients>7 years old (>40 lbs) for whomCPAP or bi-level therapy has beenprescribed.	This mask is intended to provide aninterface for application of CPAP orbi-level therapy to patients. Themask is for single patient use in thehome and multi-patient use in thehospital/institutional environment.The mask is to be used on patients>7 years old (>40 lbs) for whomCPAP or bi-level therapy has beenprescribed.	Same
Indications for use	This mask is intended to provide aninterface for application of CPAP orbi-level therapy to patients. Themask is for single patient use in thehome and multi-patient use in thehospital/ institutional environment.The mask is to be used on patients> 7 years old (> 40 lbs) for whomCPAP or bi-level therapy has beenprescribed.	This mask is intended to provide aninterface for application of CPAP orbi-level therapy to patients. Themask is for single patient use in thehome and multi-patient use in thehospital/institutional environment.The mask is to be used on patients>7 years old (>40 lbs) for whomCPAP or bi-level therapy has beenprescribed.	Same
Feature /Function	Predicate Device:Magneto Nasal Mask(K210386)	Subject Device:Therapy Mask 3100 NC/SP(K231313)	Similarities and/orDifferences
Contraindications	Use of this mask is contraindicatedin patients with the followingmetallic implants: brain shunts,aneurysm clips, splinters in theeyes, and certain neurostimulatorsused in and around the head andneck.	Use of the mask is contraindicatedfor patients and their householdmembers, caregivers, and bedpartners that may be in closevicinity to patients using the masks,that have implanted devices thatmay be affected by magnets,including but not limited to:PacemakersImplantable cardioverterdefibrillators (ICD)NeurostimulatorsMagnetic metallicimplants/electrodes/valvesplaced in upper limbs, torso, orhigher (i.e., neck and head)Cerebral spinal fluid (CSF)shunts (e.g., ventriculoperitoneal (VP) shunt)Aneurysm clipsEmbolic coilsIntracranial aneurysmintravascular flow disruptiondevicesMetallic cranial plates, screws,burr hole covers, and bonesubstitute devicesMetallic splinters in the eyeOcular implants (e.g., glaucomaimplants, retinal implants)Certain contact lenses withmetalImplants to restore hearing orbalance that have an implantedmagnet (such as cochlearimplants, implanted boneconduction hearing devices,and auditory brainstemimplants)Magnetic denture attachmentsMetallic gastrointestinal clipsMetallic stents (e.g., aneurysm,coronary, tracheobronchial,biliary)Implantable ports and pumps(e.g., insulin pumps)	The updatedcontraindicationsprovide a moredetailed list of
Feature /Function	Predicate Device:Magneto Nasal Mask(K210386)	Subject Device:Therapy Mask 3100 NC/SP(K231313)	Similarities and/orDifferences
		Hypoglossal nerve stimulators Devices labeled as MR(Magnetic Resonance) unsafe Magnetic metallic implants notlabeled for MR or not evaluatedfor safety in a magnetic field
Additional Labelingupdate	Current warningMagnets are used in the mask. Themagnetic field strength is 400 mT.Ensure the mask is kept at least 2inches (5 cm) away from any activemedical implant or medical devicethat can be impacted by themagnetic field (e.g., pacemaker,defibrillators, neurostimulators,cochlear implants, hearing aids) toavoid possible effects fromlocalized magnetic fields.	Updated WarningMagnets with a magnetic fieldstrength of 400 mT are used in themask. With the exception of thedevices identified in thecontraindication, ensure the mask iskept at least 6 inches (approx.15.24 cm) away from any othermedical implants or medical devicesthat can be impacted by themagnetic fields to avoid possibleeffects from localized magneticfields. This includes householdmembers, caregivers, and bedpartners that may be in closevicinity to patients that use themasks.	The updatedwarning extendedthe mask usedistance to avoidpossible effectsfrom localizedmagnetic fields.This extendedmask use distancewill enhance thepatient safety whenusing the masksthat containmagnets. Theupdated warningincludes possibleimpactedpopulations (e.g.,householdmembers,caregivers, and bedpartners) that maybe in close vicinityto patients that usethe masks.
Patient Population	Patients >7 years (>40 lbs)	Patients >7 years (>40 lbs)	Same
FunctionalIndication	Interface for application of CPAP orbi-level therapy to patients	Interface for application of CPAP orbi-level therapy to patients	Same
Environment ofUse	home or hospital/institutionalenvironment	home or hospital/institutionalenvironment	Same
Patient UsageType	Single patient use or multi-patientuse	Single patient use or multi-patientuse	Same
Anatomical Sites	Nose	Nose	Same
Provided Sterile orNon-Sterile	Non-sterile	Non-sterile	Same
Pressure RangeSpecification	4 cm H2O to 30 cm H2O	4 cm H2O to 30 cm H2O	Same
Feature /	Predicate Device:	Subject Device:	Similarities and/or
Function	Magneto Nasal Mask(K210386)	Therapy Mask 3100 NC/SP(K231313)	Differences
Deadspace	Nasal Cradle Cushion:Extra small size - 13.6 ml	Under the nose nasal cushion size:Extra small size - 13.6 ml	Same
Volume	Small size - 17.9 mlMedium size - 18.5 mlMedium wide size - 16.9 mlLarge size - 23.7 ml	Small size - 17.9 mlMedium size - 18.5 mlMedium wide size - 16.9 mlLarge size - 23.7 ml	Note: Nasal PillowsCushion has beenre-named asSilicone Pillows
	Nasal Pillows Cushion:Extra small size – 11.4 mlSmall size - 11.6 mlMedium size - 12.0 mlMedium wide size - 13.0 mlLarge size - 12.4 ml	Silicone Pillows Cushion:Extra small size – 11.4 mlSmall size - 11.6 mlMedium size – 12.0 mlMedium wide size - 13.0 mlLarge size - 12.4 ml	Cushion to betterdifferentiatebetween productlines. There is nochange in design,materials, or use.
Pressure Drop	Nasal Cradle Cushion:Extra small size -1.7 cm H2O @ 50 SLPM6.3 cm H2O @ 100 SLPMSmall size -1.5 cm H2O @ 50 SLPM6.5 cm H2O @ 100 SLPMMedium size -1.4 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMMedium wide size -1.6 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMLarge size -1.5 cm H2O @ 50 SLPM5.3 cm H2O @ 100 SLPMNasal Pillows Cushion:Extra small size -1.9 cm H2O @ 50 SLPM7.5 cm H2O @ 100 SLPMSmall size -2.0 cm H2O @ 50 SLPM7.2 cm H2O @ 100 SLPMMedium size –1.5 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMMedium wide size -1.6 cm H2O @ 50 SLPM6.3 cm H2O @ 100 SLPMLarge size -1.8 cm H2O @ 50 SLPM6.8 cm H2O @ 100 SLPM	Under the nose nasal cushion size:Extra small size -1.7 cm H2O @ 50 SLPM6.3 cm H2O @ 100 SLPMSmall size -1.5 cm H2O @ 50 SLPM6.5 cm H2O @ 100 SLPMMedium size -1.4 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMMedium wide size -1.6 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMLarge size -1.5 cm H2O @ 50 SLPM5.3 cm H2O @ 100 SLPMSilicone Pillows Cushion:Extra small size -1.9 cm H2O @ 50 SLPM7.5 cm H2O @ 100 SLPMSmall size -2.0 cm H2O @ 50 SLPM7.2 cm H2O @ 100 SLPMMedium size -1.5 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMMedium wide size -1.6 cm H2O @ 50 SLPM6.3 cm H2O @ 100 SLPMLarge size -1.8 cm H2O @ 50 SLPM6.8 cm H2O @ 100 SLPM	SameNote: Nasal PillowsCushion has beenre-named asSilicone PillowsCushion todifferentiatebetween productlines. There is nochange in design,materials, or use.
Sound Power andPressure Level	A-weighted Sound Power Level -28 dBAA-weighted Sound Pressure Level	A-weighted Sound Power Level –28 dBAA-weighted Sound Pressure Level	Same
	@1m: - 20 dBA	@1m: — 20 dBA
Feature /	Predicate Device:	Subject Device:	Similarities and/or
Function	Magneto Nasal Mask(K210386)	Therapy Mask 3100 NC/SP(K231313)	Differences
Total Mask Leak	9.2 SLPM @ 4 cm H2O10.8 SLPM @ 5 cm H2O17.2 SLPM @ 10 cm H2O26.7 SLPM @ 20 cm H2O34.6 SLPM @ 30 cm H2O	9.2 SLPM @ 4 cm H2O10.8 SLPM @ 5 cm H2O17.2 SLPM @ 10 cm H2O26.7 SLPM @ 20 cm H2O34.6 SLPM @ 30 cm H2O	Same
ReprocessingMethods	Air path and non-air pathcomponents - Cleaning with liquiddish detergent	Air path and non-air pathcomponents - Cleaning with liquiddish detergent	Same
	Air path components - High levelchemical and thermal disinfection	Air path components - High levelchemical and thermal disinfection
	Non-air path components - Lowlevel chemical and thermaldisinfection	Non-air path components - Lowlevel chemical and thermaldisinfection
Mask Weight	XS Pillow Mask 37.3 gS Pillow Mask 37.4 gM Pillow Mask 37.6 gMW Pillow Mask 37.7 gL Pillow Mask37.8 g	XS Pillow Mask 37.3 gS Pillow Mask 37.4 gM Pillow Mask 37.6 gMW Pillow Mask 37.7 gL Pillow Mask37.8 g	Same
	XS Cradle Mask 39.3 gS Cradle Mask 40.8 gM Cradle Mask 41.6 gMW Cradle Mask 40.9 gL Cradle Mask 43.1 g	XS Cradle Mask 39.3 gS Cradle Mask 40.8 gM Cradle Mask 41.6 gMW Cradle Mask 40.9 gL Cradle Mask 43.1 g
Exhalation/Exhaust	Built-in exhalation through themask tubing	Built-in exhalation through the masktubing	Same
Storage Conditions	Temperature: -4° to 140° F (-20° to+60°C)	Temperature: -4° to 140° F (-20° to+60°C)	Same
	Relative Humidity: 15% to 95%	Relative Humidity: 15% to 95%

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Note: SLPM is Standard Liters Per Minute. SLPM is a unit of volumetric flow rate of a gas at standard conditions for temperature and pressure (STP)

Non-Clinical Tests and/ or Clinical tests

No non-clinical and/or clinical tests summaries are submitted with this CBE submission. These labeling changes do not affect the product performance related to design outputs or specifications; therefore, additional design validation of product performance requirements was not required to implement this change.

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Standards

The Therapy Mask 3100 NC/SP has been designed per the following standards:

. ISO 17510: 2015 Medical Device - Sleep Apnoea Breathing Therapy: Masks and Application Accessories
ISO 5356-1: 2015 Anaesthetic and Respiratory Equipment - Conical Connectors: Part 1: Cones and Sockets
ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk . management process
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinoqenicity and . reproductive toxicity
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization .
ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for . leachable substances
ISO 18562-1: 2017 Biocompatibility Evaluation of Breathing Gas Pathways In Healthcare Applications Part 1: . Evaluation and Testing Within A Risk Management Process
ISO 18562-2:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications-Part 2: ● Tests for Emissions of Particulate Matter
ISO 18562-3:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications-Part 3: ● Tests for Emissions of Volatile Organic Compounds
ISO 18562-4:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications-Part 4: ● Tests for leachables in Condensate
. ISO 14971: 2019 Medical devices - Application of risk management to medical devices
ISO 17664: 2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 15223-1: 2021 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements

Conclusion

The performance and technological characteristics of the Therapy Mask 3100 NC/SP (K231313) are substantially equivalent to those of the Therapy Mask 3100 NC/SP (K210386). The differences described above do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).