(52 days)
Not Found
No
The summary describes a procedural kit for specimen retrieval and handling, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device is intended for retrieving and handling specimens for diagnostic examination, not for treating a disease or condition.
No.
The device is described as a kit for retrieving, handling, and preparing specimens for examination, not for performing the examination itself or providing a diagnosis.
No
The device description clearly states it is a "Procedural Kit" containing "items for obtaining and handling of cytologic and histological specimens," indicating it includes physical components, not just software.
Based on the provided information, the Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the kit is "intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination." Cytopathic and histological examinations are laboratory procedures performed in vitro (outside the body) on biological specimens to diagnose diseases.
- Device Description: The description reinforces this by stating the kit contains items for "obtaining and handling of cytologic and histological specimens."
While the kit itself is used during a procedure on a patient (transbronchial aspiration), its primary function is to facilitate the collection and preparation of specimens that will then be analyzed in vitro for diagnostic purposes. This aligns with the definition of an IVD device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
The fact that it doesn't mention image processing, AI, or specific anatomical sites doesn't preclude it from being an IVD. Many IVD devices are focused on specimen collection and preparation for subsequent laboratory analysis.
N/A
Intended Use / 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.
Product codes
77 EOQ
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.
0
Attachment 4
510(k) Summary
Premarket Notification [510(k)]:
TBNA Combination Cytology/Histology Procedural Kit
| 1. | Submitter: Mill-Rose Laboratories, Inc.
7310 Corporate Blvd.
Mentor, OH 44060
(440) 255-7995
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 | ||
| aspiration needle (TBAN) | ||
| of choice" | K914181 | 21 C.F.R. § 874.4680 |
| Bronchoscope (flexible or | ||
| rigid) and accessories, | ||
| Class II | ||
| MW-100 lockable syringe | ||
| (20cc) | K852607 | 21 C.F.R. § 880.5860 |
| Piston syringe, Class II | ||
| 95% EtOH fixative (50cc) | Exempt from premarket | |
| notification | 21 C.F.R. § 864.4010 | |
| General purpose reagent, | ||
| Class I |
1
| Components | 510(k) Status | Classification |
|---|---|---|
| Cytolyt preservative (30cc | ||
| vial) | Exempt from premarket | |
| notification | 21 C.F.R. § 864.4010 | |
| General purpose reagent, | ||
| Class I | ||
| Histology specimen foam | ||
| pad | Exempt from premarket | |
| notification | 21 C.F.R. § 864.3250 | |
| Specimen transport and | ||
| storage container, Class I | ||
| NaCl irrigation solution | ||
| (110cc) | Exempt from premarket | |
| notification | 21 C.F.R. § 864.4010 | |
| General purpose reagent, | ||
| Class I | ||
| Microscope slides (1" x 3") | Exempt from premarket | |
| notification | 21 C.F.R. § 864.3010 | |
| Tissue processing | ||
| 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.
2
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.
3
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
4
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