MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM

K031997 · Mallinckrodt Dar S.R.L. · BSY · Nov 25, 2003 · Anesthesiology

Device Facts

• Record ID: K031997
• Device Name: MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
• Applicant: Mallinckrodt Dar S.R.L.
• Product Code: BSY · Anesthesiology
• Decision Date: Nov 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6810
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Ty-Care/Ty-Care exel are in-line closed suction systems connecting to endotracheal or tracheostomy tubes. Device allows clinicians to suction tracheobronchial secretions without disconnecting patients from mechanical ventilators. Ty-Care is a fixed system (48-hour use); Ty-Care exel is a detachable system featuring a rotating patient-access valve (catheter replaced every 24 hours, elbow every 72 hours). Systems include suction catheter, clear plastic sleeve, irrigation port, and manual vacuum control. Used in clinical settings by healthcare professionals. Benefits include maintaining ventilation during suctioning and reducing risk of contamination/desaturation.

Clinical Evidence

Bench testing only. Biocompatibility and performance testing conducted to verify compliance with voluntary standards and product specifications. Testing confirmed that the increased duration of use for the Ty-Care/Ty-Care exel systems does not raise new safety or effectiveness concerns.

Technological Characteristics

Closed suction system with translucent catheter body and clear plastic sleeve. Features include manual vacuum control, irrigation port, and standard ISO connectors. Ty-Care exel includes a rotating patient-access valve and double swivel elbow. Available in adult, pediatric, and neonatal configurations. Sterile, single-use device.

Indications for Use

Indicated for endotracheal or tracheostomy suctioning of intubated adult, pediatric, and neonatal patients. Intended for single use only.

Regulatory Classification

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Predicate Devices

• MALLINCKRODT DAR HI-CARE (K972258)
• Ballard (Kimberly Clark) Trach-Care (K974630)
• Ballard (Kimberly Clark) Trach-Care (K964369)
• Ballard (Kimberly Clark) Trach-Care (K873810)

Submission Summary (Full Text)

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# 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: [phone] (E-mail: [e-mail].)

Date of Summary Preparation: June 26, 2003

### 2. DEVICE NAME

| Proprietary Name: | MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed<br>Suction System |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/Usual Name: | In-line closed suction system |
| Classification Name: | Tracheobronchial suction catheter<br>(73) BSY<br>Class I (General Control)<br>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

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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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| | | MALLINCKRODT<br>DAR<br>Ty-Care™ /<br>Ty-Care™ exel | MALLINCKRODT<br>DAR<br>Hi-Care | BALLARD<br>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<br>disconnecting patient from ventilator | YES** | YES | NO |
| | Allows suctioning without<br>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<br>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<br>(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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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 [phone]. 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 [phone] or [phone] 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)

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(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

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