← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K983122

# MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT (K983122)

_Mill-Rose Laboratory · EOQ · Oct 30, 1998 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K983122

## Device Facts

- **Applicant:** Mill-Rose Laboratory
- **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md)
- **Decision Date:** Oct 30, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4680
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Indications for Use

The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.

## Device Story

Procedural kit containing tools for transbronchial needle aspiration (TBNA); includes aspiration needle, lockable syringe, fixatives, irrigation solution, specimen foam pads, and microscope slides. Used by clinicians during bronchoscopy to obtain and process tissue/cell samples for pathology. Kit components facilitate specimen collection and preservation for subsequent cytopathic and histological examination. No electronic or automated processing involved.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Kit includes a transbronchial aspiration needle, 20cc lockable syringe, 95% ethanol fixative, Cytolyt preservative, histology foam pads, NaCl irrigation solution, and microscope slides. Components are standard medical/laboratory supplies. No electronic, software, or energy-based components.

## Regulatory Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

## Predicate Devices

- MRL transbronchial aspiration needle (TBAN) ([K914181](/device/K914181.md))
- MW-100 lockable syringe (20cc) ([K852607](/device/K852607.md))

## Submission Summary (Full Text)

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K983122

# Attachment 4

## 510(k) Summary

### Premarket Notification [510(k)]:

### TBNA Combination Cytology/Histology Procedural Kit

| 1. | Submitter: Mill-Rose Laboratories, Inc.<br>7310 Corporate Blvd.<br>Mentor, OH 44060<br>(440) 255-7995<br>Contact: Alan C. Poje, Director of Regulatory Affairs and Quality |
|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

This summary was prepared on August 24, 1998.

- Proprietary Name: Mill-Rose Laboratories Transbronchial Needle Aspiration 2. (TBNA) Combination Cytology/Histology Procedural Kit Common Name: none Classification Name: none
#### 3. Statement of Equivalence

All the components of the kit are either legally marketed preamendments devices, exempt from premarket notification, or have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended. The following chart lists the components, their 510(k) status, and classification.

| Components                                                    | 510(k) Status                         | Classification                                                                           |
|---------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------|
| "MRL transbronchial<br>aspiration needle (TBAN)<br>of choice" | K914181                               | 21 C.F.R. § 874.4680<br>Bronchoscope (flexible or<br>rigid) and accessories,<br>Class II |
| MW-100 lockable syringe<br>(20cc)                             | K852607                               | 21 C.F.R. § 880.5860<br>Piston syringe, Class II                                         |
| 95% EtOH fixative (50cc)                                      | Exempt from premarket<br>notification | 21 C.F.R. § 864.4010<br>General purpose reagent,<br>Class I                              |

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| Components                          | 510(k) Status                         | Classification                                                               |
|-------------------------------------|---------------------------------------|------------------------------------------------------------------------------|
| Cytolyt preservative (30cc<br>vial) | Exempt from premarket<br>notification | 21 C.F.R. § 864.4010<br>General purpose reagent,<br>Class I                  |
| Histology specimen foam<br>pad      | Exempt from premarket<br>notification | 21 C.F.R. § 864.3250<br>Specimen transport and<br>storage container, Class I |
| NaCl irrigation solution<br>(110cc) | Exempt from premarket<br>notification | 21 C.F.R. § 864.4010<br>General purpose reagent,<br>Class I                  |
| Microscope slides (1" x 3")         | Exempt from premarket<br>notification | 21 C.F.R. § 864.3010<br>Tissue processing<br>equipment, Class I              |

#### 4. Device Description

The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit contains items for obtaining and handling of cytologic and histological specimens in the context of a transbronchial aspirating needle procedure.

#### 5. Intended Use

The Transbronchial Needle Aspiration Cytology/Histology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.

#### 6. Technological Characteristics

The technological characteristics of the kit components do not vary from those of the components when used individually and not in the context of the kit.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 30 1998

Alan C. Poje Director of Regulatory Affairs and Quality Mill-Rose Laboratories, Inc. 7310 Corporate Blvd. Mentor, OH 44060

Re: K983122

Mill-Rose Laboratories Transbronchial Needle Aspiration (TBNA) Combination Cytology/Histology Procedural Kit Regulatory class: II/21 CFR 874.4680 Product Code: 77 EOQ Dated: September 4, 1998 Received: September 8, 1998

Dear Mr. Poje:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Image /page/2/Picture/10 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.

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Page 2 - Alan C. Poje

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

for

Lillian Yin
Director D

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Health Office of Device Evaluation Center for Devices and Radiological Health

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# Attachment 2

# Indications for Use Statement

## Premarket Notification [510(k)]:

# TBNA Combination Cytology/Histology Procedural Kit

Indications for Use:

The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use A (Per 21 C.F.R. § 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

Elmil a. Lynn
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT. and Radiological D 510(k) Number

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