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.

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.

AI/ML Overview

The provided text describes the 510(k) summary for the MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed Suction System, claiming substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria, specifically regarding performance metrics, sample sizes, expert involvement, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on intended use, design, operational characteristics, and materials of construction compared to predicate devices. It briefly mentions "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." This is a general statement and lacks the specific details requested in your prompt.

Therefore, most of the requested information cannot be extracted from this document.

Here's how much of your request can be answered based solely on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Hypothetical, as not explicitly stated)	Device Performance (Inferred/General claims)
Safety and Effectiveness for Intended Use	"Biocompatibility and performance testing demonstrate that... 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."
Equivalence to Predicate Devices (Key Characteristics)	Demonstrates equivalence in: Closed System, Single Patient Use, Suctioning without disconnecting ventilator, Manual vacuum control, Standard ISO connectors, Translucent catheter body, Clear plastic sleeve, Irrigation port, Rotating patient access valve (Ty-Care™ exel), Double swivel elbow, Sterility, Available in ADT, PED, INF sizes.
Duration of Use	Ty-Care™ (fixed): up to 48 hours. Ty-Care™ exel (detachable): catheter replaced after 24 hours, elbow after 72 hours.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not mention experts involved in establishing ground truth for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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

No. This is a medical device (closed suction system), not an AI-powered diagnostic or imaging device for which MRMC studies comparing human readers with and without AI assistance would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. The document only generally mentions "biocompatibility and performance testing" and "verification and validation testing" against "designated voluntary standards and product specifications." It does not detail how the "truth" or success of these tests was established.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary:
The provided 510(k) summary is designed to demonstrate substantial equivalence to predicate devices based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and results in the format requested. Information regarding specific testing methodologies, sample sizes, ground truth establishment, or expert involvement in performance criteria is absent from this document.

Summary

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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 ClosedSuction System
Common/Usual Name:	In-line closed suction system
Classification Name:	Tracheobronchial suction catheter(73) BSYClass 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.

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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.

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		MALLINCKRODTDARTy-Care™ /Ty-Care™ exel	MALLINCKRODTDARHi-Care	BALLARDTRACH-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 withoutdisconnecting patient from ventilator	YES**	YES	NO
	Allows suctioning withoutdisconnecting 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 catheterbody	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.

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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.

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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

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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)

Over-The-Counter Use

Page vii

Regulation Number and Section

§ 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.