(52 days)
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.
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.
This submission describes a kit composed of several components, not a single device with a specific performance. The regulatory review (510(k)) found the kit substantially equivalent to legally marketed predicate devices because all its components were either already cleared, exempt from notification, or had undergone their own 510(k) process. This means the individual components were likely evaluated for their individual performance and safety, but there isn't a single study describing the overall performance of the kit in terms of specific acceptance criteria.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC study, standalone performance) are not applicable to this particular 510(k) submission, as it focuses on the equivalence of a combination of components.
Here's an attempt to answer the questions based on the provided document, noting where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
Based on the provided K983122 510(k) summary, there are no specific performance acceptance criteria or reported device performance metrics for the overall kit as a single device. The submission focuses on the substantial equivalence of its individual components to already legally marketed devices. The "performance" in this context refers to the intended function of each component, which is assumed to be met based on their prior clearances or exempt status.
| Acceptance Criteria (Not Explicitly Stated for the Kit) | Reported Device Performance (Kit Equivalence) |
|---|---|
| (Implicit for individual components: e.g., sterility, material compatibility, functional integrity) | The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. This is based on the individual components' existing 510(k) clearances, exemptions, or pre-amendment status. |
| (Implicit for kit: safe and effective retrieval and handling of specimens for cytopathic and histological examination) | 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, implying expected performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) is about substantial equivalence of a medical device kit composed of pre-existing components. There is no specific test set or clinical study described in this document for the kit itself. The performance and safety of the individual components would have been established in their respective original clearances or through their general purpose exemption status.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As there is no specific test set or clinical study for the kit's performance, there's no mention of experts establishing a ground truth for such a study in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set is described for the kit's performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a medical device kit for specimen collection and preparation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a medical device kit, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no explicit mention of a ground truth being established for the kit's performance in this document. The "ground truth" for each component implicitly relates to their established safety and efficacy for their individual intended uses, as determined during their original regulatory pathways.
8. The sample size for the training set
Not applicable. This submission does not involve a training set for an algorithm or model.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this submission.
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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) 255-7995Contact: 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 transbronchialaspiration needle (TBAN)of choice" | K914181 | 21 C.F.R. § 874.4680Bronchoscope (flexible orrigid) and accessories,Class II |
| MW-100 lockable syringe(20cc) | K852607 | 21 C.F.R. § 880.5860Piston syringe, Class II |
| 95% EtOH fixative (50cc) | Exempt from premarketnotification | 21 C.F.R. § 864.4010General purpose reagent,Class I |
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| Components | 510(k) Status | Classification |
|---|---|---|
| Cytolyt preservative (30ccvial) | Exempt from premarketnotification | 21 C.F.R. § 864.4010General purpose reagent,Class I |
| Histology specimen foampad | Exempt from premarketnotification | 21 C.F.R. § 864.3250Specimen transport andstorage container, Class I |
| NaCl irrigation solution(110cc) | Exempt from premarketnotification | 21 C.F.R. § 864.4010General purpose reagent,Class I |
| Microscope slides (1" x 3") | Exempt from premarketnotification | 21 C.F.R. § 864.3010Tissue processingequipment, 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
§ 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.