(19 days)
K8977050A, K914181
Not Found
No
The device description and performance studies focus on the mechanical aspects of a biopsy needle and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is used for diagnostic purposes (submucosal aspiration biopsy) to collect tissue samples, not to treat a condition or disease.
No
Explanation: The device is a biopsy needle used to collect tissue samples. While these samples are then used for diagnostic purposes, the device itself is an instrument for sample collection, not for analysis or diagnosis.
No
The device description clearly outlines physical components like a needle, catheter, and handle mechanism, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used for submucosal aspiration biopsy of the bronchial tree." This describes a procedure performed on the patient to obtain a tissue sample.
- Device Description: The device is a needle and catheter system designed to physically collect a sample from the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device's primary function is the collection of the sample, not the analysis of it.
While the collected sample might be used for subsequent in vitro diagnostic testing (like histology or cytology), the device itself is a tool for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
Used for submucosal aspiration biopsy of the bronchial tree.
Product codes
77 KTI, 77 EOO
Device Description
The modified Lung Biopsy Needle is a sterile, disposable device, used for submucosal aspiration biopsy of the bronchial tree through the accessory channel of a bronchoscope. It consists of a 22 gauge needle, 100 cm outer catheter and handle mechanism. The handle mechanism is used to extend and retract the needle with the proximal portion inclusive of the aspiration port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bronchial tree
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)
Design Control, risk analysis and design verification activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, visual, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K8977050A, K914181
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
SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK LUNG BIOPSY RE: 1998 NEEDLE 8 DEC
510(k) Summary of Safety & Effectiveness
Submitted By: Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description: The modified Lung Biopsy Needle is a sterile, disposable device, used for submucosal aspiration biopsy of the bronchial tree through the accessory channel of a bronchoscope. It consists of a 22 gauge needle, 100 cm outer catheter and handle mechanism. The handle mechanism is used to extend and retract the needle with the proximal portion inclusive of the aspiration port.
| Trade Name: | Wilson-Cook Lung Biopsy Needle |
|---|---|
| Common/Usual Name: | Aspiration Needle |
| Classification Name/Code: | Bronchoscope Accessory 77 KTI EOQ |
| Classification: | FDA has classified similar devices as Class II as per 21 CFR § 874.4680. This device falls within the purview of the Ear, Nose and Throat Device Panel. |
| Establishment Registration Number: | 1037905 |
Validated EO cycle in accordance with AAMI Standard 11135 using an Sterility: SAL of 106.
Performance Standards: No performance standards applicable to Bronchoscope Accessories have been established by the Food and Drug Administration.
Used for submucosal aspiration biopsy of the bronchial Intended Use: tree.
Predicate Devices:
| Predicate Device | Manufacturer | Document Control
Number |
|-------------------------------------|--------------------------|----------------------------|
| Wilson-Cook Lung Biopsy
Needle | Wilson-Cook Medical Inc. | K8977050A |
| Transbronchial Aspiration
Needle | Wang/Mill-Rose | K914181 |
Substantial Equivalence:
The modified Lung Biopsy Needle is substantially equivalent to the referenced predicate devices in that it is similar with respect to technological characteristics and intended use.
Page. 10
Confidential 11/13/98
1
SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK LUNG BIOPSY RE: NEEDLE
| Characteristic | Predicate Wilson-
Cook Lung Biopsy
Needle
(K897050A) | Predicate Wang/Mill-
Rose Transbronchial
Aspiration Needle
(K914181) | Modified
Wilson-Cook
Lung Biopsy
Needle
[Subject of
"Special"
510(k)] |
|-----------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Intended Use | Biopsy of lung tissue. | Aspiration biopsy of
the bronchial tree. | Submucosal
aspiration
biopsy of the
bronchial tree. |
| Outer Catheter | Polytetrafluoroethylene
with metal hub at distal
tip. | Polytetrafluoroethylene
with metal hub at distal
tip. | Polyetheretherk
etone (PEEK)
with metal hub
at distal tip. |
| Needle | 22 GA stainless steel
needle affixed to an
inner catheter | 22 GA Needle | 22 GA stainless
steel needle. |
| Maximum Needle
Extension | 13mm | 13mm | 13mm |
| Outer Catheter
Length | 100cm | 140 cm | 100cm |
| Sterility | Sterile, Disposable | Sterile, Disposable | Sterile,
Disposable |
510(k) Summary of Safety & Effectiveness (continued)
Biocompatibility:
Reasonable assurance of biocompatibility for the patient contacting materials has been established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results.
Design Control/Risk Analysis/Design Verification:
Design Control, risk analysis and design verification activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, visual, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
Page 11
Confidential 11/13/98
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10008 8 DEC
Wilson-Cook Medical, Inc. C/O Paula Joyce QA/RÅ Manager 4900 Bethania Station Rd. Winston-Salem, NC 27105 K984157 Wilson-Cook Lung Biopsy Needle Dated: November 13, 1998 Received: November 19, 1998 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO
Dear Ms. Joyce:
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 (for the indications for use stated in the enclosure) to 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approvial), it may be subject to such additional controls. Existing major regulations affecting your 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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.
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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitn 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/cdrf/dsma/dsmamain.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Re: Special 510(k): Device odification for the Wilson-Cook Lung Biopsy Needle.
510(k) Number (if known): _ K984157
Device Name: Wilson-Cook Lung Biopsy Needle
Indications For Use:
Used for submucosal aspiration biopsy of the bronchial tree.
(PLE ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984157
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)