← Product Code [MNR](/productcode/MNR) · K260949 # Disposable Belts for Polysomnography (CNSAC) (K260949) _CNSAC Medshop GmbH · MNR · Sep 24, 2026 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260949 ## Device Facts - **Applicant:** CNSAC Medshop GmbH - **Product Code:** [MNR](/productcode/MNR.md) - **Decision Date:** Sep 24, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.2375 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Pediatric ## Indications for Use The CNSAC Disposable Belts for Polysomnography is intended to measure thoracic and/or abdominal respiratory effort during polysomnography (PSG) sleep studies in adult and pediatric patients greater than 2 years of age. The device is used with compatible polysomnography recording systems in clinical sleep laboratories or similar diagnostic environments. The belt is intended for single-patient use and is worn externally around the thorax or abdomen over clothing. ## Device Story Device is a passive, single-patient-use elastic textile belt for polysomnography (PSG). It incorporates an integrated conductive respiratory inductance plethysmography (RIP) loop and a snap-button connector. Worn externally around the thorax or abdomen over clothing, it functions as a passive sensing element. During respiration, thoracic/abdominal circumference changes alter the electrical characteristics of the RIP loop. These changes are detected by an external, compatible RIP sensor and transmitted to a PSG recording system for signal processing, display, and analysis. Used by trained healthcare professionals in clinical sleep laboratories or similar diagnostic environments. The device contains no active electronics, software, firmware, or internal power source. It aids in diagnosing sleep disorders, including sleep apnea, by providing respiratory effort data to the clinician for evaluation. ## Clinical Evidence No clinical studies were conducted. Substantial equivalence was demonstrated through bench testing, including mechanical integrity (tensile/stretching), electrical continuity, connector reliability, and functional signal performance. Comparative testing against the predicate device on five healthy adult volunteers confirmed comparable signal acquisition, stability, and morphology across various breathing patterns. Biocompatibility was verified per ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Electrical safety and EMC were evaluated at the system level per IEC 60601-1 and IEC 60601-1-2. ## Technological Characteristics Passive elastic textile belt with integrated conductive RIP loop and snap-button connector. Non-powered; no active electronics, software, or firmware. Dimensions vary for adult/pediatric use. Non-sterile. Biocompatibility per ISO 10993. System-level electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2. ## Regulatory Identification A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377. ## Predicate Devices - Nox Disposable Inductive Effort Belt ([K151361](/device/K151361.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **U.S. FOOD & DRUG** ADMINISTRATION September 24, 2026 CNSAC Medshop GmbH Arash Kianian CEO Biebelrieder St. 42 Theilheim, 97288 Germany Re: K260949 Trade/Device Name: Disposable Belts for Polysomnography (CNSAC) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: March 21, 2026 Received: March 23, 2026 Dear Arash Kianian: 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. {1} K260949 - Arash Kianian Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K260949 - Arash Kianian Page 3 assistance/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, Binoy J. Mathews-S Digitally signed by Binoy J. Mathews -S Date: 2026.09.24 13:45:52 -04'00' For James J. Lee, Ph.D. Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K260949 Device Name Disposable Belts for Polysomnography (CNSAC) Indications for Use (Describe) The CNSAC Disposable Belts for Polysomnography is intended to measure thoracic and/or abdominal respiratory effort during polysomnography (PSG) sleep studies in adult and pediatric patients greater than 2 years of age. The device is used with compatible polysomnography recording systems in clinical sleep laboratories or similar diagnostic environments. The belt is intended for single-patient use and is worn externally around the thorax or abdomen over clothing. 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.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} 510(k) Premarket Notification CNSAC Disposable PSG Belts CNSAC cardiology · neurology · sleep # 510(k) SUMMARY # Submitter Information CNSAC MedShop GmbH Biebelrieder Str. 42 97288 Theilheim Germany Contact Person: Dr. Arash Kianian Email: ark@cnsac.com Phone: +49 9303 98 41 Fax: +49 9303 98 41 3 51 Alternate Contact Person: Jennifer Gantt Elexes Medical Consulting Phone:+1 650-503-6615 | Wyoming, USA| Bengaluru, IN Email: jennifer@elexes.com Date Prepared: September 24, 2026 # Device Name Trade Name: Disposable Belts for Polysomnography (CNSAC) Common Name: Ventilatory Effort Recorder Accessory Classification Name: Breathing frequency monitor Product Code: MNR Regulation Number: 21 CFR 868.2375 Device Class: Class II # Predicate Device (K151361) Primary Predicate: Nox Disposable Inductive Effort Belt Manufacturer: Nox Medical ehf Common Name: Ventilatory Effort Recorder Accessory Classification Name: Breathing frequency monitor Product Code: MNR Regulation Number: 21 CFR 868.2375 Device Class: Class II # Device Description The CNSAC Disposable PSG Belt is a single-patient-use accessory intended for use during polysomnography (PSG) sleep studies to acquire thoracic and abdominal respiratory effort signals when used with compatible respiratory inductance plethysmography (RIP) sensors and PSG recording systems. The device consists of an elastic textile belt incorporating an integrated conductive RIP loop and snap-button connector interface. The belt is designed to be positioned around the patient's thorax and/or abdomen over light clothing during sleep {5} # **510(k) Premarket Notification** **CNSAC Disposable PSG Belts** CNSAC cardiology · neurology · sleep monitoring procedures. The device is supplied non-sterile and is intended for single-patient use only. The CNSAC Disposable PSG Belt functions as a passive sensing element within a respiratory effort monitoring system and does not contain active electronics, signal conditioning circuitry, oscillation circuitry, software, firmware, or an internal power source. During use, the integrated RIP loop is connected to a compatible external RIP sensor through the snap-button connector interface. Changes in thoracic and abdominal circumference during respiration alter the electrical characteristics of the RIP loop. These changes are detected by the external RIP sensor and transmitted to the connected PSG system for signal processing, recording, display, and analysis. The device is available in multiple sizes for adult and pediatric patients (>2 years of age). The CNSAC Disposable PSG Belt is intended for use by trained healthcare professionals in sleep laboratories, hospitals, and other clinical environments where PSG examinations are performed. The device is used as part of sleep disorder diagnostic procedures, including evaluation of patients with suspected sleep apnea and other sleep-related breathing disorders. The CNSAC Disposable PSG Belt is intended for use with compatible SOMNOmedics RIP sensors and PSG recording systems, including the SOMNOtouch RESP system. The belt connects to the external RIP sensor through a snap-button interface. Signal acquisition, processing, recording, and display are performed by the connected RIP sensor and PSG system. The belt is a passive accessory and does not contain active electronics, software, firmware, or signal-processing functions. ### Indications for Use The Disposable Belts for Polysomnography (CNSAC) is intended to measure thoracic and/or abdominal respiratory effort during polysomnography (PSG) sleep studies in adult and pediatric patients greater than 2 years of age. The device is used with compatible polysomnography recording systems in clinical sleep laboratories or similar diagnostic environments. The belt is intended for single-patient use and is worn externally around the thorax or abdomen over clothing. ### Comparison of Technological Characteristics The subject device has the same intended use and similar technological characteristics as the predicate device (K151361). Both devices are passive, non-powered accessories used during polysomnography to measure respiratory effort using respiratory inductance plethysmography (RIP) technology. Both devices consist of an elastic textile belt with an integrated inductive wire and connectors for attachment to PSG monitoring systems. Any minor differences in materials or dimensions do not affect the intended use or fundamental scientific technology and do not raise new questions of safety or effectiveness. {6} 510(k) Premarket Notification CNSAC Disposable PSG Belts CNSAC cardiology · neurology · sleep | Feature | New Device | Predicate Device | Substantial Equivalent Comments | | --- | --- | --- | --- | | | Disposable Belts for Polysomnography (CNSAC) | Nox RIP Belts and Nox RIP Belt Cables | | | Manufacturer | CNSAC MedShop GmbH | Nox Medical ehf | | | 510(k) number | K260949 | K151361 | | | Product code | MNR | MNR | Same as predicate device | | Regulation name | Ventilatory Effort Recorder | Ventilatory Effort Recorder | Same as predicate device | | Regulation number | 21 CFR 868.2375 | 21 CFR 868.2375 | Same as predicate device | | Device Class | Class II | Class II | Same as predicate device | | Indications for use | The Disposable Belts for Polysomnography (CNSAC) is intended to measure thoracic and/or abdominal respiratory effort during polysomnography (PSG) sleep studies in adult and pediatric patients greater than 2 years of age. The device is used with compatible polysomnography recording systems in clinical sleep laboratories or similar diagnostic environments. The belt is intended for single-patient use and is worn externally around the thorax or abdomen over clothing. | The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. The Nox RIP Belts are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. | Comparable intended use and clinical application. Both devices are intended for measurement of respiratory effort during polysomnography (PSG) in patients greater than 2 years of age. The differences in the described use environments and the additional specification of single-patient use and placement over clothing do not affect safety or effectiveness, as these differences do not alter the device's intended function, operating principle, or method of respiratory effort measurement. | | Device Function | Passive accessory used in conjunction with a compatible RIP sensor and PSG system for acquisition of thoracic and abdominal respiratory effort signals | Passive accessory used in conjunction with a compatible RIP sensor and PSG system for acquisition of thoracic and abdominal respiratory effort signals | Same as predicate device | | Device Design | Elastic textile RIP belt with integrated conductive wire loop and snap-button connector interface | Elastic textile RIP belt with integrated conductive wire loop and connector interface | Comparable design. Both devices use an elastic textile RIP belt with an integrated conductive wire loop and connector interface for measurement of respiratory effort. Although the connector interfaces are described differently, the difference is related to compatibility with the respective polysomnography (PSG) systems. Both connectors provide the same intended connection function. This difference does not affect the intended function or operating | {7} 510(k) Premarket Notification CNSAC Disposable PSG Belts CNSAC cardiology · neurology · sleep | | | | principle and does not raise any new questions of safety or effectiveness. | | --- | --- | --- | --- | | Technology | RIP belt with integrated conductive/inductive wire loop | RIP belt with integrated conductive/inductive wire loop | Same as predicate device | | Functional Components | Textile belt, conductive RIP loop, snap-button connector interface | Textile belt, conductive RIP loop, connector interface | Same technological principle | | Power Source / Active Electronics | No power source; contains only passive components | No power source; contains only passive components | Same | | Signal Processing | No signal processing done in Belt | No signal processing done in Belt | Same | | Sterility | Non-sterile | Non-sterile | Same as predicate device | | Environment of Use | Hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. | Hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. | Same as predicate device | | Intended User | trained healthcare professionals during supervised sleep diagnostic procedures | trained healthcare professionals during supervised sleep diagnostic procedures | Same as predicate device | | Target Patient | Adult and pediatric patients (>2 years) | Patients older than 2 years | Same as predicate device | | Sizes | Multiple belt sizes available | Multiple belt sizes available | Same as predicate device | | Type of connection | Snap connector interface to respiratory effort sensor | Snap connector interface | Same as predicate device | | Shelf Life | 24 months | Not specified | Comparable. The subject device has a labeled shelf life of 24 months, whereas no shelf life is specified in the cleared labeling of the predicate device. The 24-month shelf life of the subject device is supported by real-time aging evaluation and demonstrates that the device maintains its specified performance and integrity throughout the labeled shelf life. Therefore, the difference in shelf-life labeling does not raise any new questions of safety or effectiveness. | | Packaging Configuration | Individual non-sterile packaging | Individual non-sterile packaging | Same as predicate device. Both devices are individually packaged and supplied non-sterile. The packaging configuration is the same and therefore does not affect the safety or effectiveness of the device. | The predicate device K151361 includes both respiratory effort sensing belts (RIP Belts) and associated RIP Belt Cables intended to connect the belts to sleep diagnostic recording systems. In contrast, the subject device consists solely of disposable respiratory effort belts and does not include cables, patient lead wires, recorder interfaces, active electronics, signal conditioning circuitry, software, firmware, or other interconnection accessories. {8} 510(k) Premarket Notification CNSAC Disposable PSG Belts CNSAC cardiology · neurology · sleep Accordingly, several technological characteristics evaluated as part of K151361 are not applicable to the subject device, including belt cable performance, recorder interface compatibility, interconnection reliability, and associated accessory requirements. The subject device represents a narrower device configuration consisting solely of the passive respiratory effort belt component of the predicate technology. The subject device and the predicate RIP Belts share the same intended use, patient population, operating principle, and fundamental technological characteristics. Both devices are passive respiratory effort sensors intended to monitor thoracic and abdominal respiratory effort during sleep studies when used with compatible polysomnography or sleep diagnostic systems. Both devices employ the same fundamental respiratory effort sensing technology, contain no active electronic components, require no power source, and perform no signal processing. Any differences between the subject device and the predicate device are limited to design, material, dimensional, and manufacturing characteristics that do not alter the intended use, operating principle, or functional performance of the device. Verification testing, performance evaluation, biocompatibility assessment, packaging validation, shelf-life evaluation, and risk management activities demonstrate that these differences do not introduce new hazards, do not adversely affect device performance, and do not raise new questions of safety or effectiveness. Based on the identical intended use, equivalent operating principles, comparable performance characteristics, and reduced technological complexity relative to the complete predicate system, the CNSAC Disposable PSG Belt is substantially equivalent to the legally marketed predicate device cleared under K151361. ## Performance Data ### Performance Testing Performance testing was conducted to verify that the CNSAC Disposable PSG Belt performs as intended and to demonstrate substantial equivalence to the predicate device ### Mechanical Integrity Mechanical testing was performed to verify the structural integrity of the elastic belt material and integrated sensing components under conditions representative of intended use. Testing included tensile loading and repeated stretching to evaluate the mechanical integrity of the belt during polysomnography procedures. ### Elasticity Testing The belt was subjected to repeated expansion and contraction cycles to simulate respiratory movements occurring during sleep studies. Testing verified that the device maintained its functional characteristics and mechanical performance following repeated use-related deformation. ### Electrical Continuity The integrated conductive sensing element was evaluated for electrical continuity using resistance measurements. Testing confirmed uninterrupted electrical continuity and functional integrity of the sensing element throughout the intended operating range. ### Connector Reliability The snap-button connector interface was evaluated through repeated connection/disconnection {9} # 510(k) Premarket Notification CNSAC Disposable PSG Belts CNSAC cardiology · neurology · sleep cycles and mechanical pull-force testing. Testing verified reliable mechanical retention and electrical connectivity between the disposable belt and compatible respiratory effort sensing components. # Functional Signal Performance Testing Performance testing was conducted to evaluate the respiratory effort signal performance of the CNSAC Disposable PSG Belt and to compare its performance with the legally marketed predicate device, Nox Respiratory Effort Belt (K151361). Comparative functional performance testing was performed on five healthy adult volunteers under controlled breathing conditions. Respiratory effort signals were recorded during normal breathing, deep breathing, and rapid breathing using the CNSAC Disposable PSG Belt and the predicate device under equivalent test conditions. Recorded respiratory effort signals were evaluated with respect to signal acquisition capability, signal continuity, signal stability, waveform morphology, response to changes in respiratory effort and breathing frequency, respiratory pattern recognition, and the presence of signal loss or dropouts. All predefined acceptance criteria were met. Acceptance criteria included successful acquisition of respiratory effort signals, continuous signal acquisition without clinically significant interruptions or signal loss, stable waveform morphology, and comparable signal response to changes in breathing depth and breathing frequency between the CNSAC Disposable PSG Belt and the predicate device. # Electrical Safety and Electromagnetic Compatibility The CNSAC Disposable PSG Belt is a passive, non-powered device with no active electronics or wireless functionality. Electrical safety and electromagnetic compatibility were evaluated at the system level with compatible SOMNOmedics PSG equipment. Testing in accordance with IEC 60601-1 and IEC 60601-1-2 included CNSAC Disposable PSG Belt models within the evaluated configurations and demonstrated acceptable electrical safety and EMC performance. The testing supports that use of the belts with the compatible SOMNOmedics system does not adversely affect system electrical safety, electromagnetic compatibility, or respiratory effort signal acquisition. # Shelf-Life Evaluation Real-time shelf-life evaluation was performed using production belts aged for approximately 36 months to support the labeled 2-year (24-month) shelf life and demonstrate maintenance of device functionality, packaging integrity, and product performance throughout and beyond the claimed storage period. # Biocompatibility Biocompatibility evaluation was conducted in accordance with ISO 10993 standards, including cytotoxicity, sensitization, and irritation testing, supporting the safety of the materials used. # Clinical Testing No clinical studies were conducted. Clinical data were not required to demonstrate substantial equivalence, as the device has the same intended use and similar technological characteristics as the predicate device. # Applicable standards/guidance: - IEC 60601-1 — Medical electrical equipment – Part 1: General requirements for basic {10} # 510(k) Premarket Notification CNSAC Disposable PSG Belts CNSAC cardiology · neurology · sleep safety and essential performance — applicable to the system-level electrical safety evidence. - IEC 60601-1-2 — Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests — applicable to the system-level EMC evaluation. - ISO 10993-1:2018 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. - ISO 10993-5:2009 — Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. - ISO 10993-10:2021 — Biological evaluation of medical devices – Part 10: Tests for skin sensitization. - ISO 10993-23:2021 — Biological evaluation of medical devices – Part 23: Tests for irritation. - FDA Guidance, “Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” (September 2023) - ISO 14971:2019 — Medical devices — Application of risk management to medical devices ### Substantial Equivalence Conclusion The CNSAC Disposable PSG Belt has the same intended use and similar technological characteristics as the predicate device K151361. Performance testing demonstrates that the device is as safe and effective as the predicate device and does not raise new questions of safety or effectiveness. Therefore, the CNSAC Disposable PSG Belt is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K260949](https://fda.innolitics.com/device/K260949) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com