(11 days)
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No
The summary describes a physical aspiration needle and does not mention any software, image processing, or AI/ML terms.
No
The device is used for diagnostic biopsy (submucosal aspiration biopsy), not for treating a disease or condition.
Yes
The device is used for submucosal aspiration biopsy, which is a diagnostic procedure to obtain tissue samples for examination.
No
The intended use describes a "Transbronchial Aspiration Needle," which is a physical medical device used for biopsy. There is no mention of software as the primary component or function.
Based on the provided information, the Horizons ANSO Transbronchial Aspiration Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "submucosal aspiration biopsy of the bronchial tree" using a flexible endoscope. This describes a procedure performed on the patient to obtain a tissue sample.
- IVD Definition: In vitro diagnostics are tests performed outside the body on samples such as blood, urine, or tissue to detect diseases, conditions, or infections.
The Horizons ANSO Transbronchial Aspiration Needle is a device used to collect the sample, not to analyze it in vitro. The analysis of the collected biopsy sample would likely be an in vitro diagnostic process, but the needle itself is a surgical/biopsy device.
N/A
Intended Use / Indications for Use
Horizons ANSO Transbronchial Aspiration Needle is intended to be used in the flexible endescope for submucosal aspiration biopsy of the bronchial tree.
Product codes
EOO
Device Description
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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
bronchial tree
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)
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Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a simple, black and white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2002
Horizons International Corp. c/o Rafic Saleh P.O. Box 7273 Ponce, PR 00732-7273
Re: K022546
Trade/Device Name: Horizons ANSO Transbronchial Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: EOO Dated: July 25, 2002 Received: August 1, 2002
Dear Mr. Saleh:
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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
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Page 2 - Rafic Saleh
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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6.1 Indication for Use
510K INDICATION FOR USE STATEMENT
KO22546 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Horizons ANSO Transbronchial Aspiration Needle Device Name:
Horizons International Corp. Applicant Name:
Indications for Use:
Horizons ANSO Transbronchial Aspiration Needle is intended to be used in the flexible endescope for submucosal aspiration biopsy of the bronchial tree.
Horizons International Corp.
Signature: __
Prescription Use
(Per 21 CFR 801.109)
Karen Bohrer
(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises
510(k) Number