MYSHELL

• K Number: K040498
• Device Name: MYSHELL
• Manufacturer: SEDAT S.A.
• Date Cleared: 2004-07-02 ( 127 days)
• Product Code: DTL
• Regulation Number: 870.4290

Intended Use

MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures. The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures. MYSHELL and its accessories are indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (.098") used in interventional procedures.

Device Description

MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (<.098"). The watertight double hemostatic silicone valve is manipulated by a valve opening mechanism on the external body of MYSHELL. The opening mechanism allows for precise control of the internal valve: press gradually on the mechanism for a controlled opening, push the mechanism entirely in for a complete and locked opening, or completely close the valve by depressing on the mechanism in its locked position.

Predicate Devices

K991102

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components and manual control, with no mention of AI/ML terms or functionalities.

Therapeutic

No
MYSHELL is described as a y-connector/hemostatic valve and its indications for use focus on maintaining a seal around other diagnostic/interventional devices, assisting manipulation, and facilitating procedures, rather than directly treating a condition or disease.

Diagnostic

No
MYSHELL is described as a y-connector/hemostatic valve that maintains a seal around diagnostic/interventional devices, assisting manipulation during interventional procedures. It does not perform diagnostic functions itself.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical y-connector/hemostatic valve with a mechanical valve opening mechanism, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that MYSHELL is for "maintaining a seal around diagnostic/interventional devices" and "assisting, manipulating and maintaining a seal around diagnostic/interventional devices". This describes a device used during a medical procedure to manage the access point, not a device used to perform a diagnostic test on a sample taken from the body.
• Device Description: The description details a "y-connector/hemostatic valve" with a "watertight double hemostatic silicone valve". This is a mechanical device designed to control fluid and device passage, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in samples
  • Providing diagnostic information about a patient's health status
  • Reagents, calibrators, or controls

The device is clearly intended for use as an accessory during interventional procedures to manage the access site and prevent bleeding, which falls under the category of a medical device used in vivo (within the body) rather than in vitro (in glass/outside the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

0

K040498

2/24/2004

JUL 0 2 2004

510(k) Summary C.

| Applicant | Sedat, Inc.
76 Bedford Street, #33
Lexington, MA 02420
Contact: Jean-Pierre Desseignes
Telephone: [phone]
Facsimile: 781/674-3115
Email: [e-mail] |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Sedat
France Address
Contact |
| Date | February 24, 2004 |
| Device Name | MYSHELL |
| Common Name | Y-Connector/Hemostatic Valve
(per 21 CFR 870.4290) |
| Summary of
Substantial
Equivalence | MYSHELL is substantially equivalent in respect to the intended use, design and method of operation of the Copilot™ Bleedback Control Valve manufactured by Guidant Corporation (K991102). |
| Device Description | MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (