(64 days)
Not Found
Not Found
No
The description focuses on a mechanical device for stent insertion and does not mention any AI/ML components or functions.
No.
The Pilling Weck Surgical Y Stent Forceps is described as a surgical instrument used to insert tracheobronchial stents, not a device that directly provides therapy or treatment itself.
No
The device, Pilling Weck Surgical Y Stent Forceps, is described as a tool for inserting tracheobronchial stents during ENT procedures, mechanically holding stent limbs for insertion and then releasing them. Its function is interventional/surgical, not diagnostic (identifying or characterizing a condition).
No
The device description clearly describes a physical, hand-controlled forcep with a grasping tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a surgical instrument (forceps) used to physically insert a stent into the tracheobronchial tree during a surgical procedure. It does not involve testing or analyzing samples from the body.
- Intended Use: The intended use is for a surgical procedure (inserting a stent), not for diagnostic testing.
Therefore, the Pilling Weck Surgical Y Stent Forceps is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures
Product codes
77 EOQ
Device Description
The Stent Forceps/(Bronchoscope(Flexible or Rigid) consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial
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)
Karl Storz Stent Applicator Forceps
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
4/27/99
Image /page/0/Picture/1 description: The image shows the logo for "Pilling Weck". The logo consists of a stylized "W" symbol on the left, followed by the text "Pilling Weck" in a bold, serif font. The "W" symbol has a diamond shape above it.
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510 (k) Summary
- Submitter Name, Address, and Date of Submission. 1.
Mrs. Julie A Beaumont Group Regulatory Affairs Technician Pilling Weck Group Tall Pines Park Jaffrey, New Hampshire 03452
(603) 532-7706 Telephone: (603) 532-6179 Facsimile: jbeaumont@tfx.com E-Mail: Contact: Same as above
- Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Pilling Weck Surgical Y Stent Forceps / (Bronchoscope (Flexible or Rigid)
Common Name: Stent Forceps
Proprietary Name: Stent Forceps/(Bronchoscope(Flexible or Rigid)
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Identification of the legally marketed device to which 3. the submitter claims equivalence.
The Stent Forceps/(Bronchoscope(Flexible or Rigid) is substantially equivalent to the Karl Storz Stent Applicator Forceps. -
Description of the Device. 4 .
The Stent Forceps/(Bronchoscope(Flexible or Rigid)
A Telefiex Company
One Weck Drive, P.O. Box 12600 Research Triangle Park, North Carolina 27709 (919) 544-8000
Image /page/0/Figure/17 description: The image shows a curved line. The line is thin and black. The curve is concave up.
1
consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn.
Intended Use of the Device. 5 .
The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures
Summary of Technological Characteristics. 6.
The Pilling Weck Surgical Y Stent Forceps(Bronchoscope (Flexible or Rigid)are substantially equivalent to the predicate devices, since the basic features, designs and intended uses are the same. The differences between the Pilling Weck Surgical devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol resembling three abstract human profiles or flowing lines, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1999
Mrs. Julie A. Beaumont Group Regulatory Affairs Technician Pilling Weck Group Tall Pines Park Jaffrey, New Hampshire 03452
Re: K990547 Trade Name: Pilling Weck Surgical Stent Forceps Regulatory Class: II Product Code: 77 EOQ Dated: February 19, 1999 Received: February 22, 1999
Dear Mrs. Beaumont:
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 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 (OS) 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 .
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Page 2 - Mrs. Julie A. Beaumont
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 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/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kaqus47 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid) is to inset tracheobronchial stents during ENT procedures
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use_ | Over-The-Counter Use_ |
|---|---|
| ------------------- | ----------------------- |
(Per 21 CFR 801.109) For Harry, Juablut
(Division Sign-Off)
Division of Ophthalmic Devices
| 510(k) Number | K990547 |
|---|---|
| --------------- | --------- |