(151 days)
No
The document describes a mechanical suction system and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "closed suction system" for "endotracheal / tracheostomy suction" of intubated patients and its purpose is to suction "tracheobronchial secretions," which directly addresses a medical condition or ailment.
No
Explanation: The device description states it is a "closed suction system" for "suction of adult and pediatric intubated patients." Its purpose is to remove tracheobronchial secretions, which is a treatment or maintenance function, not a diagnostic one.
No
The device description clearly describes a physical suction catheter system with hardware components designed to connect to endotracheal or tracheostomy tubes. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "closed suction system" used for "endotracheal / tracheostomy suction of adult and pediatric intubated patients." This is a physical intervention to remove secretions from the airway.
- Lack of Sample Analysis: The device does not analyze any biological samples to provide diagnostic information. It is a tool for a medical procedure.
Therefore, this device falls under the category of a medical device used for treatment or management, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ty-Care/Ty-Care exel Closed Suction System is intended for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.
Product codes
BSY
Device Description
Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheobronchial
Indicated Patient Age Range
adult and pediatric intubated patients (including neonates)
Intended User / Care Setting
attending health professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility and performance testing demonstrate that MALLINCKRODT DAR Ty-Care™ / Ty-Care Closed Suction System complies with designated voluntary standards and fulfills product specifications. Verification and validation testing demonstrates that the increased duration of use raises no new issues of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K972258, K974630, K964369, K873810
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a handwritten number, "K031997", in black ink on a white background. The numbers are written in a simple, slightly slanted style. The image is cropped closely around the number, with no other objects or details visible.
510(k) Summary MALLINCKRODT DAR S.r.l. Ty-Care™ / Ty-Care™ exel Closed Suction System (per 21 CFR 807.92)
SPONSOR/APPLICANT NAME, ADDRESS, TELEPHONE NUMBER 1.
MALLINCKRODT DAR S.R.L. via G. Bove, 2/4/6/8 I-41037 Mirandola (MODENA), ITALY
Contact Person: Giuseppe Tomasini Telephone: 011 39 0535 617922 (E-mail: giuseppe.tomasini@mkg.com.)
Date of Summary Preparation: June 26, 2003
2. DEVICE NAME
| Proprietary Name: | MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed
Suction System |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/Usual Name: | In-line closed suction system |
| Classification Name: | Tracheobronchial suction catheter
(73) BSY
Class I (General Control)
21 CFR 868.6810 |
3. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED
MALLINCKRODT DAR HI-CARE (K972258)
Ballard (Kimberly Clark) Trach-Care (K974630, K964369, K873810)
DEVICE DESCRIPTION 4.
Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced
1
after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.
క. INTENDED USE/INDICATIONS FOR USE
The Ty-Care/Ty-Care exel Closed Suction System is intended for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.
A STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF 6. THE DEVICE COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED
MALLINCKRODT DAR S.R.L. makes the claim of substantial equivalence with the H-Care based on intended use, design, operational characteristics, and materials of construction. A side-by-side comparison of the MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed Suction System to the systems cited is provided in Table H-1 below.
2
| | | MALLINCKRODT
DAR
Ty-Care™ /
Ty-Care™ exel | MALLINCKRODT
DAR
Hi-Care | BALLARD
TRACH-CARE |
|-----------------|------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------|-----------------------|
| 510(k) number | | Proposed | K972258 | K974630 |
| | | | | K964369 |
| | | | | K873810 |
| Characteristics | Closed System | YES | YES | YES |
| | Indicated for single patient use | YES | YES | YES |
| | Labeled for replacement after 24 hours | NO* | YES | NO |
| | Allows catheter replacement without
disconnecting patient from ventilator | YES** | YES | NO |
| | Allows suctioning without
disconnecting patient from ventilator | YES | YES | YES |
| | Manual control of vacuum | YES | YES | YES |
| | Standard ISO connectors | YES | YES | YES |
| | Translucent catheter body | YES | YES | YES |
| | Clear plastic sleeve covering catheter
body | YES | YES | YES |
| | Irrigation port | YES | YES | Not specified |
| | Rotating patient access valve | YES** | YES | NO |
| | Double swivel elbow (DSE) | YES | NO | YES |
| Sterility | Sterile | YES | YES | YES |
| Design | Available in adult (ADT), pediatric
(PED), and Neonatal (INF) | YES | YES | Not specified |
Table H-1. Comparison of the Ty-Care™/Ty-Care™ exel Closed Suction System with Predicate Devices
- For the Ty-Care™ ("fixed" version), the complete system shall be replaced after 48 hours (as the related IFU clearly states). The Ty-Care™ exel ( detachable system) features a suction catheter that should be replaced after 24 hours while the elbow and other components are replaced after 72 hours. The Hi-Care suction catheter maximum use is 24 hours, as stated in the related Instructions for Use.
** Available only for the Ty-Care™ exel version.
7. TESTING
Biocompatibility and performance testing demonstrate that MALLINCKRODT DAR Ty-Care™ / Ty-Care Closed Suction System complies with designated voluntary standards and fulfills product specifications. Verification and validation testing demonstrates that the increased duration of use raises no new issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
NOV 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Giuseppe Tomasini Regulatory Affairs & Quality System Manager Mallinckrodt DAR, S.R.L. Via Giacomo Bove, 2/4/6/8 Mirandola (Modena) I-41037 ITALY
Re: K031997
Trade/Device Name: Mallinckrodt DAR S.RL. Ty-Care / Ty-Care Exel Closed Suction System Regulation Number: 868.6810 Regulation Name: Tracheobronchial Suction Catheter Regulatory Class: I Product Code: BSY Dated: October 16, 2003 Received: October 17, 2003
Dear Mr. Tomasini:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
4
Page 2 -Mr. Tomasini
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Quls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
General Information
Device Name: MALLINCKRODT DAR Ty-Care™ and Ty-Care™ exel Closed Suction System
Indications for Use:
This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE — CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
fo Hundh
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031997
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Page vii