(32 days)
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
The provided 510(k) summary for the "DUAL PURPOSE CLOSED CATHETER" does not include specific acceptance criteria or detailed results from the performance testing. Instead, it makes a general statement about substantial equivalence.
Here's a breakdown of the information that is available and what is missing for your specific questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: Not explicitly enumerated in the provided text beyond the general statement of "substantially equivalent."
The document states: "Based on the results of performance testing conducted at HAUSER Laboratories the Spirit Medical Systems. Inc. DUAL PURPOSE CLOSED CATHETER is substantially equivalent to the Jinotti™ Closed Suction/Oxygen Catheter Systems manufactured and distributed by MedCare Medical Group, Inc." This indicates that performance testing was done, but the details of what was tested, the specific metrics, and the acceptance thresholds are not included in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: The testing was "conducted at HAUSER Laboratories," but details regarding the type of samples (e.g., in vitro, animal, human), their origin, or whether the study was retrospective or prospective are not provided. Given the nature of a catheter, it's highly likely this involved in-vitro and/or animal studies rather than human clinical trials for a 510(k) submission, especially from this era.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is largely irrelevant for a device of this type (a physical catheter) undergoing performance testing for substantial equivalence. The "ground truth" would likely be objective measurements from laboratory tests, rather than expert interpretation of images or other diagnostic data. Therefore, no information is provided.
4. Adjudication method for the test set
- Not applicable/provided for the reasons stated in point 3.
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
- MRMC Study: No.
- Effect Size: Not applicable. This device is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used
- While not explicitly stated, for a physical medical device like a catheter seeking substantial equivalence, the "ground truth" for performance testing (likely flow rates, suction efficiency, material compatibility, strength, etc.) would be established through objective laboratory measurements and engineering standards, not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices. The comparison is made against the predicate device's established performance characteristics.
8. The sample size for the training set
- Not applicable/provided. This refers to a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/provided.
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SEP 2 2 1998
DUAL PURPOSE CLOSED CATHETER 510(k) Premarket Notification Spirit Medical Systems, Inc.
510(k) SUMMARY
Kg82945
Date Summary was Prepared ____________________________________________________________________________________________________________________________________________________
Peter M. Fitzgerald Printed name of person required to submit 510(k) Signature of person required to sp omit 510(K) PRESIDENT
Title of person submitting 510(k)
Submitter:
SPIRIT MEDICAL SYSTEMS, INC. 16267 Whitestone Dr. Parker, CO. 80134 (303) 840-1299
Establishment Registration Number:
Spirit Medical Systems, Inc. is not currently registered with the FDA. Spirit Medical Systems, Inc. will submit form FDA-2891A (Initial Registration of Device Establishment), to the Food and Drug Administration prior to establishing a manufacturing facility.
| Proprietary Name: | DUAL PURPOSE CLOSED CATHETER |
|---|---|
| Common/Usual Name: | Dual purpose oxygen/suction catheter |
| Classification Name: | Tracheobronchial Suction Catheter |
| Classification: | Dual purpose oxygen/suction catheter systems such as DUALPURPOSE CLOSED CATHETER falls under the classification of 21CFR 868.6810 "Tracheobronchial suction catheter" regulatory ClassI. |
| Predicate device: | The predicate device is Jinotti™ Closed Suction/Oxygen Catheter,(510(k) #K833375) manufactured and distributed by MedCareMedical Group, Inc. |
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DUAL PURPOSE CLOSED CATHETER 510(k) Premarket Notification Spirit Medical Systems, Inc.
510(k) Summary - continued
Description of 510(k) submission device:
Product Description:
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
Intended use:
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
Comparison to Predicate Device:
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER and the above named substantially equivalent device have the same intended use in that they are a disposable sterile dual purpose closed oxygen/suction catheters designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. Both the DUAL PURPOSE CLOSED CATHETER and the Jontti™ Closed Suction/Oxygen catheter provide maximum suction efficiency into the airway without compromising patient safety as well as additional gas flow into the airway for the purpose of improving alveolar ventilation, prior to and immediately following suctioning,
Summary of Performance Testing:
Based on the results of performance testing conducted at HAUSER Laboratories the Spirit Medical Systems. Inc. DUAL PURPOSE CLOSED CATHETER is substantially equivalent to the Jinotti™ Closed Suction/Oxygen Catheter Systems manufactured and distributed by MedCare Medical Group, Inc.
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SEP 2 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey T. Sawyer Spirit Medical Systems, Inc. 16267 Whitestone Drive Parker, CO 80134
Re : K982945 Dual Purpose Closed Catheter Regulatory Class: I (one) Product Code: BSY Dated: August 17, 1998 Received: August 21, 1998
Dear Mr. Sawyer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. -- -------------------------------------------------------------------------------------------------------------------------------------
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Page 2 - Mr. Jeffrey T. Sawyer
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN) : K98 29 S
DEVICE NAME :
INDICATIONS FOR USE:
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The-Counter-Use(Optional Format 1-2-96) |
Page A-2
| (Division Sign-Off) | Mark Kramer |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K982945 |
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.