K Number
K963727
Device Name
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
Manufacturer
Date Cleared
1997-02-11

(148 days)

Product Code
Regulation Number
874.3880
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.
Device Description
The Xomed Hoffman H/A Coated Long-Term Ventilation Tube is comprised of two components, using three biocompatible materials. One component of the device is an outer titanium tube with a polished inner lumen. A Hydroxylapatite (H/A) coating covers a portion of the exterior surface of the outer tube where it is positioned against the bony wall of the ear canal when surgically placed. The second component is a removable inner tube made of fluoroplastic. This liner can be removed and replaced by the surgeon should occulsion of the liner lumen occur. The liner design precludes the internal migration of the polymer liner into the middle ear space.
More Information

Not Found

No
The device description and intended use describe a physical medical device (ventilation tube) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

Yes.
The device is intended to provide long-term ventilation or drainage of the middle ear, which relates to the treatment of a disease or condition.

No
The device is a ventilation tube for the ear, used for drainage and communication between the outer and middle ear. It does not perform any diagnostic function.

No

The device description clearly states it is comprised of physical components (titanium tube, fluoroplastic liner) and is surgically placed, indicating it is a hardware medical device.

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

Here's why:

  • Intended Use: The intended use clearly states the device is for providing ventilation or drainage of the middle ear when inserted under the tympanic membrane. This is a surgical procedure performed directly on a patient's body.
  • Device Description: The description details a physical implantable device (a ventilation tube) made of titanium and fluoroplastic.
  • Anatomical Site: The device is used in the outer and middle ear, which are parts of the human body.
  • IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform tests on samples.

The device is a surgical implant used for therapeutic purposes (ventilation/drainage), not for diagnostic testing of biological samples.

N/A

Intended Use / Indications for Use

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.

Product codes

77 ETD

Device Description

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube is comprised of two components, using three biocompatible materials. One component of the device is an outer titanium tube with a polished inner lumen. A Hydroxylapatite (H/A) coating covers a portion of the exterior surface of the outer tube where it is positioned against the bony wall of the ear canal when surgically placed. The second component is a removable inner tube made of fluoroplastic. This liner can be removed and replaced by the surgeon should occulsion of the liner lumen occur. The liner design precludes the internal migration of the polymer liner into the middle ear space.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

(Preamendment), K900267, (Unknown)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.

0

K96 3727

Image /page/0/Picture/1 description: The image shows the logo for XOMED Surgical Products. The logo is in black and white and features the word "XOMED" in large, bold letters. Below the word "XOMED" is the phrase "SURGICAL PRODUCTS" in smaller letters. Below the phrase is a circular symbol with a cross inside.

FEB 11 1997

510(k) Summary Hoffman Long-Term H/A Coated Ventilation Tube (with Liner)

Date Prepared 1.0

September 5, 1996

2.0 Submitter (Contact)

David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Hoffman H/A Coated Long-Term Ventilation Tube with Liner Proprietary Name:

Long Term Vent Tube Common Name:

Classification Name: Tympanostomy Tube

Device Classification 5.0

Class II: 21CFR 874.3880 Tier 2 Typanostomy Tube Procode 77 ETD

6.0 Device Description

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube is comprised of two components, using three biocompatible materials. One component of the device is an outer titanium tube with a polished inner lumen. A Hydroxylapatite (H/A) coating covers a portion of the exterior surface of the outer tube where it is positioned against the bony wall of the ear canal when surgically placed. The second component is a removable inner tube made of fluoroplastic. This liner can be removed and replaced by the surgeon should occulsion of the liner lumen occur. The liner design precludes the internal migration of the polymer liner into the middle ear space.

1

7.0 Intended Use

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.

8.0 Substantial Equivalence

The Hoffman H/A Coated Long-Term Ventilation Tube with Liner is substantially equivalent to other currently marketed long-term ventilation tubes in that it has the same intended use, the same materials and/or equivalent design characteristics as shown in the predicate device labeling. The substantially equivalent ventilation tubes are as follows:

| Xomed Silverstein Permanent Aeration Tube (SPAT)

[Xomed Surgical Products, Inc](Preamendment)
Jahn Hydroxylvent™ Tube w/ fluoroplastic liner
[Smith & Nephew/Richards](K900267)
Fluoroplastic/Titanium Ventilation Tubes
[Smith & Nephew/Richards](Unknown)