(184 days)
Model # ECD03-A:
The EnsoETM is a thermal regulating device, intended to:
• connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
• allow enteral administration of fluids,
• and provide gastric decompression and suctioning.
Model # ECD04-A:
The EnsoETM is a thermal regulating device, intended to:
• connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature,
• allow enteral administration of fluids,
• and provide gastric decompression and suctioning.
The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.
The provided text is a U.S. FDA 510(k) Premarket Notification document for the EnsoETM device. This document describes a medical device, its intended use, and the non-clinical performance testing conducted to demonstrate its substantial equivalence to previously cleared predicate devices.
The request asks for information relevant to the acceptance criteria and study that proves a device meets the acceptance criteria, specifically in the context of an AI/human-in-the-loop study. However, the provided document does not describe an AI/human-in-the-loop study, nor does it discuss ground truth establishment for such a study, nor does it mention AI or machine learning in any context.
The "acceptance criteria" and "device performance" described in the document relate to non-clinical performance testing of a physical medical device (EnsoETM), an esophageal thermal regulation device with capabilities for enteral fluid administration and gastric decompression. The testing described focuses on the device's physical properties, such as tensile strength, burst strength, leakage, flow rate, resistance to vacuum, and connector properties, to ensure it functions as intended and safely when used with external temperature management systems.
Therefore, I cannot fulfill the request as it pertains to AI-related acceptance criteria, MRMC studies, ground truth establishment, or training set details because this information is not present in the provided text.
I can, however, extract the acceptance criteria and demonstrated performance for the physical device's non-clinical testing as described in the document:
Based on the provided FDA 510(k) document for the EnsoETM device, here is a summary of the non-clinical performance testing and conclusions related to meeting acceptance criteria:
The "acceptance criteria" in this context are the successful demonstration that the subject devices (EnsoETM models ECD03-A and ECD04-A) meet performance requirements and are substantially equivalent to the predicate devices (EnsoETM models ECD01-A and ECD02-A), particularly with the new ENFit connector for enteral administration. The "study" refers to a series of non-clinical, laboratory-based performance tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Non-clinical performance testing was conducted to demonstrate the technological characteristics of the subject devices are substantially equivalent to the predicate devices." For each test, the "Discussion" implicitly serves as the reported device performance demonstrating that the acceptance criteria (i.e., suitability, ability to withstand pressures, prevention of leakage, capability for flow, etc.) were met.
| Acceptance Criteria (Inferred from Test Objective) | Reported Device Performance (as stated in "Discussion") |
|---|---|
| Tensile force: Demonstrate suitability of ENFit connector and joint for insertion/removal. | "Tensile force testing demonstrated the ENFit connector and ENFit connector joint on the subject devices are suitable for use, including insertion into and removal from the esophagus." |
| Gastric lumen burst strength: Withstand operating pressures from an enteral administration system. | "Gastric lumen burst strength testing demonstrated the gastric lumen of the subject devices can withstand the operating pressures supplied by an enteral administration system." |
| Gastric lumen leakage: Prevent escape of enterally administered fluids. | "Gastric lumen leakage testing demonstrated the gastric lumen, gastric lumen connector, and gastric lumen connector joint of the subject devices do not allow enterally administered fluids to escape the gastric lumen." |
| Gastric lumen flow rate: Capable of providing flow for clinically used enteral feeding fluids. | "Gastric lumen flow rate testing demonstrated the gastric lumen of the subject devices is capable of providing flow of fluids representative of those clinically used for enteral feeding in acute care facilities." |
| Resistance to vacuum: Capable of performing gastric decompression and suctioning. | "Resistance to vacuum testing demonstrated the subject devices are capable of performing gastric decompression and suctioning." |
| Positive pressure leakage: ENFit connector does not leak fluid under pressure. | "Positive pressure liquid leakage testing demonstrated the ENFit connector does not leak fluid while under pressure." |
| Leakage by pressure decay: ENFit connector does not leak fluid under pressure. | "Leakage by pressure decay testing demonstrated the ENFit connector does not leak fluid while under pressure." |
| Stress cracking: ENFit connector does not fail under typical use-case stresses. | "Stress cracking testing demonstrated the ENFit connector does not fail when subjected to typical use-case stresses." |
| Resistance to separation from axial load: ENFit connector does not inadvertently separate under typical use-case axial loads. | "Resistance to separation from axial load testing demonstrated the ENFit connector does not inadvertently separate when subjected to typical use-case axial loads." |
| Resistance to separation from unscrewing: ENFit connector does not inadvertently separate under typical use-case torques. | "Resistance to separation from unscrewing testing demonstrate the ENFit connector does not inadvertently separate when subjected to typical use-case torques." |
| Resistance to overriding: ENFit connector does not override threads under typical use-case torques. | "Resistance to overriding testing demonstrated the ENFit connector does not override the threads when subjected to typical use-case torques." |
| Disconnection by unscrewing: ENFit connector capable of being disconnected by end-user with reasonable torque. | "Disconnection by unscrewing demonstrated the ENFit connector is capable of being disconnected by the end user with a reasonable amount of torque." |
| Dimensional verification: Dimensions of ENFit connector satisfy ISO 80369-3:2016 requirements. | "Dimensional verification demonstrated the dimensions of the ENFit connector satisfy the dimensional requirements of ISO 80369-3:2016." |
| Flexural modulus: Material of ENFit connector satisfies ISO 80369-3:2016 flexural modulus requirements. | "Flexural modulus verification demonstrated the material used to manufacture the ENFit connector satisfies the flexural modulus requirements of ISO 80369-3:2016." |
2. Sample Size Used for the Test Set and Data Provenance:
The document concerns non-clinical, laboratory-based performance testing of a physical device. It does not provide specific sample sizes (e.g., number of devices tested for each parameter) or data provenance in terms of country of origin or retrospective/prospective nature, as these are typically not reported for such engineering tests in a 510(k) summary. The tests are implicit to be conducted under controlled laboratory conditions to demonstrate device performance characteristics.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the document describes non-clinical engineering performance testing of a physical device, not an AI or diagnostic imaging study requiring expert labeling or ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes non-clinical engineering performance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance, which is not the subject of this 510(k).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The type of Ground Truth used:
This information is not applicable as the document describes non-clinical engineering performance testing. The "ground truth" for these tests would be the established engineering standards, specifications, and physical laws against which the device's performance is measured (e.g., the specified burst pressure a lumen must withstand, or the dimensional requirements of an ISO standard).
8. The sample size for the training set:
This information is not applicable as the document describes non-clinical engineering performance testing, not an AI or machine learning study.
9. How the ground truth for the training set was established:
This information is not applicable as the document describes non-clinical engineering performance testing, not an AI or machine learning study.
Conclusion from the document regarding meeting acceptance criteria:
The "Conclusion" section of the document states: "The results of all performance testing demonstrate the subject devices have technological characteristics that do not raise new questions of safety or effectiveness when compared to the predicate devices. Therefore, the subject devices are substantially equivalent to the predicate devices." This directly indicates that the device met the non-clinical acceptance criteria established for substantial equivalence.
{0}------------------------------------------------
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.
January 5, 2018
Attune Medical Erik Kulstad President/CEO 3440 S. Dearborn St. #215-South Chicago, Illinois 60616
Re: K172029
Trade/Device Name: EnsoETM, Models ECD03-A and ECD04-A Regulation Number: 21 CFR 870.5910 Regulation Name: Esophageal Thermal Regulation Device Regulatory Class: Class II Product Code: PLA Dated: December 1, 2017 Received: December 5, 2017
Dear Erik Kulstad:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
SECTION 4: Indications for Use Statement
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K172029 |
| Device Name | EnsoETM |
| Indications for Use (Describe) | |
| Model # ECD03-A:The EnsoETM is a thermal regulating device, intended to:• connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision TemperatureManagement System to control patient temperature,• allow enteral administration of fluids,• and provide gastric decompression and suctioning. | |
| Model # ECD04-A:The EnsoETM is a thermal regulating device, intended to:• connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature,• allow enteral administration of fluids,• and provide gastric decompression and suctioning. | |
| 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
"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 (8/14)
Page 1 of 1
PSC Publishing Scraces (301) 443-6740 EF
{3}------------------------------------------------
Summary of Safety and Effectiveness
Submitter / 510(k) Holder
| Company: | Attune Medical |
|---|---|
| Address: | 3440 S. Dearborn St.#215-SouthChicago, IL 60616 |
| Phone: | +1-312-725-4756 |
| Contact Person: | Erik KulstadCEO/President |
| Date Prepared: | June 30, 2017 |
| Device Name & Classification | |
| Trade Name: | EnsoETM |
| Model Number(s): | ECD03-A, ECD04-A |
| Classification Name: | Esophageal Thermal Regulation Device (21 CFR 870.5910) |
| Product Code: | PLA |
| Class: | II |
Predicate Devices
-
Attune Medical EnsoETM (model #: ECD01-A); K170009
-
Attune Medical EnsoETM (model #: ECD02-A); K152450
Reference Device
- Maquet Critical Care Ab Edi Catheter ENFit; K153688
Device Description
The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.
{4}------------------------------------------------
Indications for Use (Subject Device 1; Model #: ECD03-A)
The EnsoETM is a thermal regulating device, intended to:
- . connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
- allow enteral administration of fluids,
- and provide gastric decompression and suctioning.
Indications for Use (Subject Device 2; Model #: ECD04-A)
The EnsoETM is a thermal regulating device, intended to:
- connect to a Cincinnati Sub-Zero Blanketrol III or Blanketrol III Hyper-Hypothermia System to control patient temperature,
- . allow enteral administration of fluids,
- and provide gastric decompression and suctioning.
Technological Characteristics
The EnsoETM product family consists of four distinct models: the ECD01-A (Predicate Device 1 cleared under K170009), ECD02-A (Predicate Device 2 cleared under K152450), ECD03-A (Subject Device 1), and ECD04-A (Subject Device 2). Table 1 describes the differences between the four models. Device characteristics not described in Table 1 are identical for all models.
| Model # | Coolant LumenFittings | Gastric LumenFittings | Intended heatexchanger | Enteral administrationof fluids? |
|---|---|---|---|---|
| ECD01-A(PredicateDevice 1) | Clik-Titeconnectors | 5° silicone taper | Stryker/Gaymar Medi-Therm III or StrykerAltrix | No |
| ECD02-A(PredicateDevice 2) | Colder PLC seriesconnectors | 5° silicone taper | Cincinnati Sub-ZeroBlanketrol II orBlanketrol III | No |
| ECD03-A(SubjectDevice 1) | Clik-Titeconnectors | Male ENFitconnector | Stryker/Gaymar Medi-Therm III or StrykerAltrix | Yes |
| ECD04-A(SubjectDevice 2) | Colder PLC seriesconnectors | Male ENFitconnector | Cincinnati Sub-ZeroBlanketrol II orBlanketrol III | Yes |
Table 1: Differences between EnsoETM models
Non-Clinical Performance Testing
Non-clinical performance testing was conducted to demonstrate the technological characteristics of the subject devices are substantially equivalent to the predicate devices. The following tests were performed:
{5}------------------------------------------------
| Test performed | Discussion |
|---|---|
| Tensile force | Tensile force testing demonstrated the ENFit connector and ENFit connector joint on the subject devices are suitable for use, including insertion into and removal from the esophagus. |
| Gastric lumenburst strength | Gastric lumen burst strength testing demonstrated the gastric lumen of the subject devices can withstand the operating pressures supplied by an enteral administration system. |
| Gastric lumenleakage | Gastric lumen leakage testing demonstrated the gastric lumen, gastric lumen connector, and gastric lumen connector joint of the subject devices do not allow enterally administered fluids to escape the gastric lumen. |
| Gastric lumenflow rate | Gastric lumen flow rate testing demonstrated the gastric lumen of the subject devices is capable of providing flow of fluids representative of those clinically used for enteral feeding in acute care facilities. |
| Resistance tovacuum | Resistance to vacuum testing demonstrated the subject devices are capable of performing gastric decompression and suctioning. |
| Positive pressureleakage | Positive pressure liquid leakage testing demonstrated the ENFit connector does not leak fluid while under pressure. |
| Leakage bypressure decay | Leakage by pressure decay testing demonstrated the ENFit connector does not leak fluid while under pressure. |
| Stress cracking | Stress cracking testing demonstrated the ENFit connector does not fail when subjected to typical use-case stresses. |
| Resistance toseparation fromaxial load | Resistance to separation from axial load testing demonstrated the ENFit connector does not inadvertently separate when subjected to typical use-case axial loads. |
| Resistance toseparation fromunscrewing | Resistance to separation from unscrewing testing demonstrate the ENFit connector does not inadvertently separate when subjected to typical use-case torques. |
| Resistance tooverriding | Resistance to overriding testing demonstrated the ENFit connector does not override the threads when subjected to typical use-case torques. |
| Disconnection byunscrewing | Disconnection by unscrewing demonstrated the ENFit connector is capable of being disconnected by the end user with a reasonable amount of torque. |
| Dimensionalverification | Dimensional verification demonstrated the dimensions of the ENFit connector satisfy the dimensional requirements of ISO 80369-3:2016. |
| Flexural modulus | Flexural modulus verification demonstrated the material used to manufacture the ENFit connector satisfies the flexural modulus requirements of ISO 80369-3:2016. |
Conclusion
The results of all performance testing demonstrate the subject devices have technological characteristics that do not raise new questions of safety or effectiveness when compared to the predicate devices. Therefore, the subject devices are substantially equivalent to the predicate devices.
§ 870.5910 Esophageal thermal regulation device.
(a)
Identification. An esophageal thermal regulation device is a prescription device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting materials must be demonstrated to be biocompatible.
(2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical integrity testing.
(ii) Testing to determine temperature change rate(s).
(iii) Testing to demonstrate compatibility with the indicated external controller.
(iv) Shelf life testing.
(3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use.
(4) Labeling must include the following:
(i) Detailed insertion instructions.
(ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction.
(iii) The operating parameters, name, and model number of the indicated external controller.
(iv) The intended duration of use.