CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue. November 9, 2021 GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, Helsinki FI-00510 Finland Re: K211171 Trade/Device Name: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP Dear Joel Kent: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 21, 2021. Specifically, FDA is updating this SE Letter as an administrative correction to your Indications for Use form. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Todd Courtney, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (301) 796-6371, todd.courtney@fda.hhs.gov. Sincerely, Todd D. Courtney -S Todd Courtney 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 {1}------------------------------------------------ Image /page/1/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, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 21, 2021 GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, Helsinki FI-00510 Finland Re: K211171 Trade/Device Name: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, EsCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP Dated: September 23, 2021 Received: September 27, 2021 Dear Joel Kent: 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/cfpm/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. {2}------------------------------------------------ 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 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 (QS) 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 53 1 -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-continung-education/cdrl-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). > Sincerelv. Todd D. Courtney -ર Todd Courtnev 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 {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211171 #### Device Name CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOVE and accessories #### Indications for Use (Describe) The CARESCAPE Respiratory Modules, (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a decorative flourish. The logo is simple and recognizable, and it is associated with a well-known and respected company. ### 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Owner/Contact/Date (807.92(a)(1): | Date: | October 21, 2021 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner/Submitter: | GE Healthcare Finland Oy<br>Kuortaneenkatu 2<br>00510 Helsinki<br>FINLAND | | Primary Contact Person: | Joel Kent<br>Senior Regulatory Affairs Manager<br>GE Healthcare<br>Phone: 617-851-0943<br>E-mail: joel.kent@ge.com | | Secondary Contact Person: | Monica Morrison<br>Sr. Regulatory Affairs Director<br>GE Healthcare<br>E-mail: monica.morrison@ge.com<br><br>Anna Pehrsson<br>Regulatory Affairs Leader<br>GE Healthcare<br>E-mail: anna.pehrsson@ge.com | | Device names (807.92(a)(2)): | | | Trade Name: | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-SCAIOVE and accessories | | Common/Usual Name: | Respiratory gas module and accessories | | Classification Names: | 21 CFR 868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous Phase<br>21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase<br>21 CFR 868.1850 Spirometer, Monitoring (W/WO Alarm) | {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font inside. There are decorative swirls around the letters. The blue color is a light shade, and the overall design is simple and recognizable. 21 CFR 868.2600 Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 21 CFR 868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous-Phase (Anesthetic Conc.) 21 CFR 868.1730 Computer, Oxygen-Uptake 21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) 21 CFR 868.1620 Analyzer, Gas, Halothane Gaseous-Phase (Anesthetic Conc.) 21 CFR 868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) 21 CFR 868.1500 Analyzer, Gas, Isoflurane Gaseous-Phase (Anesthetic Concentration) 21 CFR 868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Primary Product Code CCK Subsequent Product Code: CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP Predicate Device(s) K183394 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, (807.92(a)(3): E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories Device Description The CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-(807.92(a)(4)): sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, EsCAiOVE and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients. > Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production Page 2 of 11 510(k) SUMMARY K211171 Page **2** of 11 {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable. (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the signals detected by the module sensors, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system. The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device. This 510(k) introduces two new module models in the CARESCAPE Respiratory Modules family: E-sCAiOE and EsCAiOVE. These new module models include added hardware compared to the modules cleared in K183394. The operation, measured parameters and performance specifications of the EsCAiOE and E-sCAiOVE is identical to E-sCAiO and EsCAiOV when used with the current module host devices cleared in the USA. The added modules E-sCAiOE and EsCAiOVE have the same software as CARESCAPE Respiratory Modules cleared in K183394. {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. Decorative flourishes surround the circle, adding to the logo's classic and recognizable design. The logo is simple, yet elegant. The indications for use are edited to include the added modules. There are no other changes to the indications for use. The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-Intended Use: (807.92(a)(5): sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, EsCAiOVE) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients. > When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to en sure specified measurement accuracy. > These modules are intended for use by qualified medical personnel only. Technology (807.92(a)(6)): The fundamental scientific technology of the CARESCAPE Respiratory Modules and accessories is the same as in the predicate devices (K183394). There are no changes to the measured parameters or calculations done by the host devices. > A summary of the main changes compared to the predicate device is listed below. {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The circle is surrounded by decorative flourishes, giving it a classic and recognizable appearance. Product Comparison versus Predicate Main Features: | Module<br>Characteristics | Predicate CARESCAPE<br>Respiratory Modules, E-sCO, E-<br>sCOV, E-sCOVX, E-sCAiO, E-<br>sCAiOV, E-sCAiOVX and<br>accessories (K183394) | Proposed CARESCAPE<br>Respiratory Modules, E-sCO,<br>E-sCOV, E-sCOVX, E-sCAiO,<br>E-sCAiOV, E-sCAiOVX, E-<br>sCAiOE, E-sCAiOVE and<br>accessories | Discussion of<br>Differences | 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| Indications for<br>use | The CARESCAPE Respiratory<br>Modules (E-sCO, E-sCOV, E-<br>sCOVX, E-sCAiO, E-sCAiOV, E-<br>sCAiOVX) are indicated for use<br>with a host device for monitoring<br>respiratory parameters (CO2, O2,<br>N2O, anesthetic agents, anesthetic<br>a gent identification, and<br>respiratory rate) and ventilatory<br>parameters (airway pressure, flow<br>and volume) of adult, pediatric,<br>and neonatal patients and gas<br>exchange parameters (VCO2,<br>VO2) of adult and pediatric<br>patients.<br>When monitoring neonatal or other<br>patients that have high respiration<br>rate or low tidal volume these<br>modules shall be used within the<br>limits of respiration rates and tidal<br>volumes to ensure specified<br>measurement accuracy.<br>These modules are intended for<br>use by qualified medical personnel<br>only. | The CARESCAPE Respiratory<br>Modules (E-sCO, E-sCOV, E-<br>sCOVX, E-sCAiO, E-sCAiOV,<br>E-sCAiOVX, E-sCAiOE and E-<br>sCAiOVE) are indicated for use<br>with a host device for monitoring<br>respiratory parameters (CO2, O2,<br>N2O, anesthetic agents, anesthetic<br>a gent identification, and<br>respiratory rate) and ventilatory<br>parameters (airway pressure, flow<br>and volume) of adult, pediatric,<br>and neonatal patients and gas<br>exchange parameters (VCO2,<br>VO2) of adult and pediatric<br>patients.<br>When monitoring neonatal or<br>other patients that have high<br>respiration rate or low tidal<br>volume these modules shall be<br>used within the limits of<br>respiration rates and tidal volumes<br>to ensure specified measurement<br>accuracy.<br>These modules are intended for<br>use by qualified medical<br>personnel only. | Equivalent<br>Editorial change to add<br>models E-sCAiOE and E-<br>sCAiOVE to the<br>indications for use<br>statement.<br>The change does not<br>significantly affect safety<br>and/or effectiveness. | | | Physical Properties | | | | Module size (H x<br>W x D) | 112 x 37 x 205 mm<br>(4.4 x 1.5 x 8.7 in) | 112 x 37 x 205 mm<br>(4.4 x 1.5 x 8.7 in) | Identical | | Module weight | 0.7 kg (1.5 lb) | 0.7 kg (1.5 lb) | Identical | | Parameter specifications | | | | | Gas sampling<br>flow rate | $120 \pm 20$ ml/min | $120 \pm 20$ ml/min | Identical | | Respiration<br>Rate:<br>Measurement<br>range | 4 to 100 breaths/min | 4 to 100 breaths/min | Identical | | Respiration<br>Rate: Breath<br>detection | 1 vol% peak to peak change in CO2<br>level | 1 vol% peak to peak change in<br>CO2 level | Identical | | | Measurements of CO2, N2O and anesthetic agent concentrations and identification of anesthetic agents | | | | Measurement<br>principle | Non-dispersive Infrared sensor | Non-dispersive Infrared sensor | Identical | | CO2<br>Measurement<br>range | 0 to 15 vol%<br>(0 to 15 kPa)<br>(0 to 113 mmHg) | 0 to 15 vol%<br>(0 to 15 kPa)<br>(0 to 113 mmHg) | Identical | | CO2 Accuracy | $\pm$ (0.2vol%+2% of reading) | $\pm$ (0.2vol%+2% of reading) | Identical | | N2O<br>Measurement<br>range | 0...100vol% | 0...100vol% | Identical | | N2O Accuracy | $\pm$ (2 vol% + 2% of reading)<br>$\pm$ (2 vol%+8%of reading for<br>concentrations 85...100 vol% | $\pm$ (2 vol% + 2% of reading)<br>$\pm$ (2 vol%+8%of reading for<br>concentrations 85...100 vol% | Identical | | Anesthetic<br>agents<br>measured | Halothane, Enflurane, Isoflurane,<br>Sevoflurane, Desfurane | Halothane, Enflurane, Isoflurane,<br>Sevoflurane, Desfurane | Identical | | Anesthetic<br>agent<br>Measurement<br>ranges | Hal, Enf, Iso: 0 to 6 vol%<br>Sev: 0 to 8 vol%<br>Des: 0 to 20 vol% | Hal, Enf, Iso: 0 to 6 vol%<br>Sev: 0 to 8 vol%<br>Des: 0 to 20 vol% | Identical | | Anesthetic<br>agents Accuracy | $\pm$ (0.15vol%+5%ofreading) | $\pm$ (0.15vol%+5%ofreading) | Identical | | | Measurement of oxygen concentration | | | | Measurement<br>principle | Differential paramagnetic<br>measurement | Differential paramagnetic<br>measurement | Identical | | Measurement<br>range | 0 to 100 vol% | 0 to 100 vol% | Identical | | Accuracy | $\pm$ (1 vol%+2% of reading) | $\pm$ (1 vol%+2% of reading) | Identical | | Spirometry measurements | | | | | Measurement<br>principle | Pressure signals conducted to the<br>module from D-Lite or Pedi-Lite<br>airway adapters by a double lumen<br>tube | Pressure signals conducted to the<br>module from D-Lite or Pedi-Lite<br>airway adapters by a double<br>lumen tube | Identical | | Airway<br>pressure<br>Measurement<br>range | -20...+100 cmH2O | -20...+100 cmH2O | Identical | | Airway<br>Pressure<br>Accuracy | ±1 cmH2O | ±1 cmH2O | Identical | | Airway Flow<br>Measurement<br>range | -100...+100 l/min. (adults)<br>-25...+25 l/min (pediatric) | -100...+100 l/min. (adults)<br>-25...+25 l/min (pediatric) | Identical | | Tidal volume<br>Measurement<br>range | 150...2000 ml(adults)<br>5...300 ml (pediatric) | 150...2000 ml(adults)<br>5...300 ml (pediatric) | Identical | | Tidal Volume<br>Accuracy | ±6% or 30 ml adult<br>±6% or 4 ml pediatric | ±6% or 30 ml adult<br>±6% or 4 ml pediatric…