(27 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description and performance study sections are also empty, further indicating a lack of information about advanced computational methods.
Yes
The device is used in the treatment of various medical conditions such as Dry Eye symptoms, ocular dryness secondary to contact lens use, and complications due to Dry Eye after surgery, which are therapeutic applications.
No
The device is a lacrimal plug used in the treatment of various dry eye conditions. Its purpose is therapeutic, not diagnostic, as it treats symptoms and conditions rather than identifying or diagnosing them.
No
The provided text describes a physical medical device (lacrimal plugs) and does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of dry eye symptoms and related conditions by physically blocking the tear ducts. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The device is a physical plug inserted into the lacrimal duct, which is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OPAQUE Herrick Lacrimal Plugs may be used in the treatment of: · Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation. · For treatment of ocular dryness secondary to contact lens use. · To enhance the efficacy of topical ocular medications. · After surgery to provent complications due to Dry Fye. · For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases. OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).
Product codes (comma separated list FDA assigned to the subject device)
LZV
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
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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N/A
0
Image /page/0/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 the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lacrimedics, Inc. c/o Mr. Jerry Henderson RA/QA Specialist 310 Prune Alley Eastsound, Wa 98245
245
Re: K021831
Trade/Device Name: Opaque Herrick Lacrimal Plug@0.3, 0.5, and 0.7mm Regulation Number: Unclassified Regulation Name: Lacrimal Plug Regulatory Class: Unclassified Product Code: LZV Dated: May 31, 2002 Received: June 4, 2002
Dear Mr. Henderson:
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.
1 2002
ារបរ
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.
1
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
2
510(k) Number (if known): K021831
Device Name: Opaque Herrick Lacrimal Plug®
Indications for Use:
OPAQUE Herrick Lacrimal Plugs may be used in the treatment of: · Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation.
· For treatment of ocular dryness secondary to contact lens use.
· To enhance the efficacy of topical ocular medications.
· After surgery to provent complications due to Dry Fye.
· For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases.
OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109) Qusannow Jones for DRC