(266 days)
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.
The provided text describes the 510(k) summary for the Covidien SuperDimension® Triple Needle Cytology Brush. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with specific numerical thresholds for performance metrics. Instead, it states that the device "met the required specifications for the completed tests and performed similarly to the predicate devices." The performance evaluation is based on demonstrating substantial equivalence to predicate devices, rather than achieving pre-defined quantitative performance targets.
However, based on the described "Performance Data," we can infer the categories of performance evaluated:
| Category of Performance | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | - Radiographic visibility- Catheter tensile strength- Dimensional accuracy- Ability to simulate use cases- Trackability | Met required specifications; similar to predicate devices. |
| Durability/Stability | - Shelf life (per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09)- Distribution integrity (per ASTM D4169-09) | Met required specifications; similar to predicate devices. |
| Sterilization | - Sterility (per ISO 11135-1) | Met required specifications; similar to predicate devices. |
| Biocompatibility | - Cytotoxicity, irritation, sensitization (per ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10) | Met required specifications; similar to predicate devices. |
| Functional (In Vivo) | - Ability to collect tissue specimens- Safety (no adverse events/complications in the animal model) | Demonstrated tissue collection and safety in a porcine model; similar to predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document mentions "In-vitro and in-vivo testing" was performed, but does not specify the sample sizes used for these tests. For the in-vivo testing, it was conducted "in a porcine model," indicating an animal study, not human data. The data provenance is described as:
- In-vitro testing: Laboratory-based, likely conducted by the manufacturer.
- In-vivo testing: Porcine model (animal study).
There is no mention of human retrospective or prospective data for the performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. Given that the testing involved in-vitro and in-vivo (animal model) studies, the "ground truth" would likely be established through objective measurements (for in-vitro tests) and pathological examination of collected animal tissue, possibly by veterinarians or animal pathologists. However, the specific number and qualifications of experts are not stated.
4. Adjudication Method for the Test Set:
This information is not provided. As the testing primarily involved objective measurements and animal studies, a formal adjudication method for human consensus on ground truth (like 2+1 or 3+1) would not be applicable in the absence of human clinical data or expert evaluation of test results.
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:
No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in this context. The device described is a physical medical instrument (cytology brush), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Based on the described testing:
- For in-vitro tests, the ground truth would be based on objective physical and material measurements against established engineering specifications and industry standards.
- For in-vivo testing in a porcine model, the ground truth for tissue collection would likely be pathological examination of collected animal tissue samples to confirm the presence and adequacy of collected cells/tissue. Safety would be assessed through observation and potentially post-mortem examination.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical instrument, and there is no mention of an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set mentioned for this physical device.
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Image /page/0/Picture/0 description: The image shows the word "COVIDIEN" in bold, sans-serif font. To the left of the word is a black square with a white cross in the center. The cross is formed by two perpendicular white rectangles, creating a medical symbol.
510(k) Summary K130357 Covidien IIc, dba superDimension Inc. SuperDimension® Triple Needle Cytology Brush
| Date Prepared: | 11/4/2013 | |
|---|---|---|
| 510(k) Applicant: | Covidien llc, formerly registered as superDimension Inc.161 Cheshire Lane Suite 100Plymouth, MN 55441 U.S.A. | |
| Contract Person: | Deborah Fleetham , Manager Regulatory AffairsPhone: 763-210-4091Fax: 763-210-4098Email : deborah.fleetham@covidien.com | NOV 0 6 2013 |
| Name of Device : | ||
| Trade Name : | superDimension® Triple Needle Cytology Brush | |
| Common Name: | Bronchial Biopsy Brush | |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories21 CFR Part 874.4680 | |
| Product code: | BTG |
Equivalent Legally-Marketed Devices:
K834402 Gastrointestinal Sheath Brush (KOG) by Hobbs Medical, Inc. K944650 Wang Bronchial Needle Brush (EOQ) by ConMed
Description:
The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.
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Intended Use:
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Summary of Substantial Equivalence:
The superTrax Triple Needle-Tipped Cytology brush is substantially equivalent to the ConMed Needle-Tipped Cytology Brush and the Hobbs Cytology Brush predicate devices in the following attributes:
- Indications for Use .
- Mechanism of action .
- Length .
- . Sterilization technique
- Design .
- Size .
- Materials .
- Packaging
- Performance Characteristics 0
The difference between the predicate devices and the superDimension Triple Needle Cytology Brush is that the predicate devices have one, larger brush on the distal end compared to three smaller, flexible brushes on the distal end of the superDimension Triple Needle Cytology Brush.
Performance Data:
In-vitro and in-vivo testing has been performed on all components, subassemblies, and /or full devices. The results showed that the device met the required specifications for the completed tests and performed similarly to the predicate devices. Testing included the following:
- In Vitro Testing .
- Radiographic Testing o
- Catheter Tensile Testing o
- Dimensional Testing o
- 0 Simulated Use Testing
- Trackability Testing O
- Shelf Life Testing per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09 0
- Distribution Testing per ASTM D4169-09 o
- Sterilization Testing per ISO 11135-1 o
- 0 Biocompatibility Testing (cytotoxicity, irritation, sensitization) per ISO 10993-1. ISO 10993-5, ISO 10993-7, ISO 10993-10
- In Vivo Testing in a porcine model
- o Tissue Collection
- o Safety Testing
Clinical Data:
.
Clinical tests were not required to validate the design of the SuperDimension® Triple Needle Cytology Brush due to the extensive history of similar devices.
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Conclusion :
Based on the intended use, technological characteristics, and results from safety and performance testing, the superDimension Triple Needle Cytology Brush is substantially. equivalent to the legally marketed predicate devices, Gastrointestinal Sheath Brush (KOG) by Hobbs Medical, Inc. K834402, and the Wang Bronchial Needle Brush (EOQ) by ConMed K944650.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 6, 2013
Covidien Llc c/o Ms. Deborah Fleetham Manager, Regulatory Affairs 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441
Re: K130357
Trade/Device Name: Superdimension Triple-Needle Cytology Brush Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: BTG Dated: September 27, 2013 Received: September 30, 2013
Dear Ms. Fleetham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class 11 (Special Controls) or class 111 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Deborah Fleetham
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica|Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130357
Device Name: superDimension® Triple Needle Cytology Brush
Indications For Use:
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park
Page 1 of 1
§ 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.