(81 days)
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No
The summary describes a mechanical instrument (forcep and telescope) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for removal or biopsy procedures, which are diagnostic or interventional rather than therapeutic in nature.
No
The device is described as an optical forcep for foreign body removal or biopsy procedures, which are interventional or sample collection procedures, not diagnostic ones. While the biopsy sample might later be used for diagnosis, the device itself is not performing the diagnostic function.
No
The device description explicitly states it consists of a "Telescope" and a "Biopsy Forcep," which are hardware components.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for "Tracheobronchial or Esophageal foreign body removal or biopsy procedures." This is a surgical or interventional procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Components: The components (Telescope and Biopsy Forcep) are instruments used for visualization and tissue collection during a procedure, not for analyzing a sample.
Therefore, based on the provided information, this device falls under the category of a surgical instrument rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Optical Forcep is to be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
Product codes
JEK, EOX, and EWY
Device Description
The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tracheobronchial, Esophageal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
MAY 1 4 1939
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510(K) Summary
1990561
1. Submitter Name, Address, and Date of Submission.
Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034
(800) 523-6507 Telephone Number (215) 643-7930 Fax
Contact: Same as above.
2. Name of the Device, Common, Proprietary (if known), and Classification.
- Biopsy Forcep and Telescope Classification Name: Common Name: Optical Forcep Pilling Weck Surgical Optical Forcep Proprietary Name:
-
- Identification of the legally marketed device to which the submitter claims equivalence.
Pilling Weck Surgical Optical Forcep is substantially equivalent to Storz Vocal Cord Stripping Instrument
4. Description of the Device.
The Optical Forcep consists of two components
- a. Telescope
- b. Biopsy Forcep
5. Intended Use of the Device.
The Optical Forcep is to be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures.
6. Summary of Technological Characteristics.
The technological characteristics are the same as, or equivalent to, predicate devices by Storz Vocal Cord Stripping Instruments.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 1999
Ms. Elizabeth Lazaro Regulatory Affairs Associate Pilling Weck Surgical 420 Delaware Drive Fort Washington, Pennsylvania 19034
K990561 Re: Trade Name: Optical Forcep Regulatory Class: II Product Code: JEK, EOX, and EWY Dated: February 17, 1999 Received: February 22, 1999
Dear Ms. Lazaro:
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 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 requirement, 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.
2
Page 2 – Ms. Elizabeth Lazaro
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) 594-4595. 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,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) Number (if known):
Device Name: Pilling Weck Surgical Optical Forcep
Indications for Use:
To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
(PLEASE 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 General Restorative Devices K99056
510(k) Number.
Prescription Use \$\times$ or Over-
The-Counter Use __
(Per 21 CFR 801.1 09)