(204 days)
Not Found
No
The summary describes a physical medical device (a plug) made of a specific material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to temporarily block tear drainage for the treatment of dry eye syndrome and other ocular surface diseases, which is a therapeutic function.
No
The device is a medical plug intended to temporarily block tear drainage for the treatment of dry eye syndrome and related conditions. While it can be used to "determine the potential effectiveness of a non-absorbable punctal occlusion device," its primary function is therapeutic (blocking tear drainage), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a physical, monofilament synthetic absorbable device made from poly(p-dioxanone), intended for physical insertion into the lacrimal drainage system. It is not software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Riverpoint Medical Absorbable Canalicular Plugs are physical devices inserted into the lacrimal drainage system to block tear drainage. They are used for the temporary treatment of dry eye syndrome and related conditions.
- Lack of Biological Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is purely mechanical obstruction.
Therefore, the device's intended use and mechanism of action do not align with the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Riverpoint Medical Absorbable Canalicular Plugs are intended to temporarily block tear drainage by the obstruction of the canaliculus in the lacrimal drainage system. The Absorbable Canalicular Plugs are used for the temporary treatment of dry eye syndrome, and the dry eye components of various ocular surface diseases including contact lens intolerance secondary to dry eye. The Absorbable Canalicular Plugs can be used in the treatment of dry eye following ocular surgery or to enhance the efficacy of topical medicines and/or ocular lubricants. The Riverpoint Medical Absorbable Canalicular Plugs may also be used to determine the potential effectiveness of a non-absorbable punctal occlusion device.
Product codes (comma separated list FDA assigned to the subject device)
LZU
Device Description
The Riverpoint Medical PDO Absorbable Canalicular Plug is a monofilament synthetic absorbable device prepared from poly(p-dioxanone). PDO Absorbable Canalicular Plugs are available undyed or violet. When dyed, only FDA-approved color additives such as D&C Violet No. 2 are used. PDO Absorbable Canalicular Plugs are used to temporarily block tear drainage by the occlusion of the lacrimal canaliculi for approximately 180 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus in the lacrimal drainage system
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)
Non-clinical performance testing for the Riverpoint Medical Absorbable Canalicular Plugs included sterilization validation per ISO11135-1:2007 - Sterilization of Health Care Products Ethylene Oxide Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices, biocompatibility testing per ISO10993-1:2009 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems, and a simulated use Usability Validation performed per EN62366: 2008-Medical devices - Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical Absorbable Canalicular Plug performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines extending from their heads, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Riverpoint Medical Mr. Edwin Anderson Director of Quality and Regulatory 825 NE 25th Avenue Portland, OR 97232
Re: K150288
Trade/Device Name: PDO Absorbable Canalicular Plug Regulation Number: 21 CFR Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LZU Dated: July 17, 2015 Received: July 20, 2015
Dear Mr. Anderson:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150288/S002
Device Name PDO Absorbable Canalicular Plug
Indications for Use (Describe)
The Riverpoint Medical Absorbable Canalicular Plugs are intended to temporarily block tear drainage by the obstruction of the canaliculus in the lacrimal drainage system. The Absorbable Canalicular Plugs are used for the temporary treatment of dry eye syndrome, and the dry eye components of various ocular surface diseases including contact lens intolerance secondary to dry eye. The Absorbable Canalicular Plugs can be used in the treatment of dry eye following ocular surgery or to enhance the efficacy of topical medicines and/or ocular lubricants. The Riverpoint Medical Absorbable Canalicular Plugs may also be used to determine the potential effectiveness of a nonabsorbable punctal occlusion device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of the letters "RP" inside of a rounded green square. To the right of the square is the word "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller letters underneath.
510(k) SUMMARY
Riverpoint Medical 's PDO Absorbable Canalicular Plug
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave. |
| Portland, OR 97232 | |
| Phone Number: | (503) 517-8001 or 866 445-4923 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Edwin Anderson |
| (503) 517-8001 | |
| Date of Preparation: | February 3, 2015 |
Device Name
| Trade Name: | PDO Absorbable Canalicular Plug |
|---|---|
| Common or Usual Names: | Punctum/Punctal Plug, Intracanalicular Plug, Canalicular Plug |
| Classification Name: | Plug, Punctal |
Device Classification
| FDA Class: | Unclassified |
|---|---|
| Product Classification: | Unclassified |
| Classification Code: | LZU |
| Review Panel | Ophthalmic |
| Premarket Review | Office of Device Evaluation |
| Division of Ophthalmic and Ear, Nose and Throat Devices | |
| Intraocular and Corneal Implants Devices Branch |
Predicate Devices
K140711 - Comfortear® Lacrisolve™ Absorbable Punctum Plug -Paragon BioTeck, Inc.
Device Description:
The Riverpoint Medical PDO Absorbable Canalicular Plug is a monofilament synthetic absorbable device prepared from poly(p-dioxanone). PDO Absorbable Canalicular Plugs are available undyed or violet. When dyed, only FDA-approved color additives such as D&C Violet No. 2 are used. PDO Absorbable Canalicular Plugs are used to temporarily block tear drainage by the occlusion of the lacrimal canaliculi for approximately 180 days.
4
Image /page/4/Picture/0 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters "RP" inside of a green rounded square. To the right of the square is the text "RIVERPOINT" in bold black letters, with the word "MEDICAL" in smaller letters underneath.
Intended Use / Indications for Use
The Riverpoint Medical Absorbable Canalicular Plugs are intended to temporarily block tear drainage by the obstruction of the canaliculus in the lacrimal drainage system. The Absorbable Canalicular Plugs are used for the temporary treatment of dry eye syndrome, and the dry eye components of various ocular surface diseases including contact lens intolerance secondary to dry eve. The Absorbable Canalicular Plugs can be used in the treatment of dry eve following ocular surgery or to enhance the efficacy of topical medicines and/or ocular lubricants. The Riverpoint Medical Absorbable Canalicular Plugs may also be used to determine the potential effectiveness of a non-absorbable punctal occlusion device.
Technological Characteristics
The Riverpoint Medical Absorbable Canalicular Plugs are provided sterilized via ethylene oxide, for single use with two plugs per package. Plugs are available in 0.2mm, 0.4mm and 0.5mm diameters.
Substantial Equivalence
The Riverpoint Medical Absorbable Canalicular Plug is as safe and effective as the Comfortear® Lacrisolve™ Absorbable Punctum Plug. The Riverpoint Medical Absorbable Canalicular Plugs have the same intended use and similar indications for use, principles of operation, and technical characteristics, including implant duration, material, shape, color additives, diameter availability, sterilization method, and insertion or removal method as the predicate device, see the following table. The Riverpoint Medical Absorbable Canalicular Pluqs minor technological differences as compared to the predicate device do not raise new issues of safety or effectiveness. Performance, biocompatibility and sterility testing demonstrated that the Riverpoint Medical product is as safe and effective as the predicate device and additional testing is performed on each lot of product to verify that requirements have been met prior to release. The Riverpoint Medical Absorbable Canalicular Plugs are substantially equivalent to the predicate device.
| Device
Technological
Characteristic | Riverpoint Medical PDO Absorbable
Canalicular Plug | Paragon Bioteck, Inc.,Comfortear®
Lacrisolve™ Absorbable Punctum
Plugs (K140711) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Riverpoint Medical Absorbable
Canalicular Plugs are intended to temporarily
block tear drainage by the obstruction of the
canaliculus in the lacrimal drainage system.
The Absorbable Canalicular Plugs are used
for the temporary treatment of dry eye
syndrome, and the dry eye components of
various ocular surface diseases including
contact lens intolerance secondary to dryeye. The Absorbable Canalicular Plugs can
be used in the treatment of dry eye following
ocular surgery or to enhance the efficacy of
topical medicines and/or ocular
lubricants. The Riverpoint Medical
Absorbable Canalicular Plugs may also be
used to determine the potential effectiveness
of a non-absorbable punctal occlusion | The Comfortear® Lacrisolve™
Absorbable Punctum Plugs are intended
to temporarily block tear drainage by the
occlusion of the canaliculus in order to:
• Determine the potential effectiveness
of permanent occlusion,
• Temporarily treat dry eye syndrome,
and the dry eye components of
various ocular surface diseases,
• Temporarily enhance the efficacy of
topical medications or ocular
lubricants,
• Temporarily treat contact lens
intolerance secondary to dry eye,
and
• Temporarily treat dry eye after ocular
surgery |
5
Image /page/5/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of the letters "RP" inside of a green rounded square. To the right of the square is the text "RIVERPOINT" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it.
| Device
Technological
Characteristic | Riverpoint Medical PDO Absorbable
Canalicular Plug | Paragon Bioteck, Inc., Comfortear®
Lacrisolve™ Absorbable Punctum
Plugs (K140711) |
|-------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------|
| | device. | |
| Intracanalicular
Punctum Plug | Yes | Yes |
| Intended
Duration | Approximately 180 Days | Approximately 180 Days |
| Material | Polydioxanone (PDO) | Polydioxanone (PDO) |
| Color Additive | D&C Violet No. 2 | D&C Violet No. 2 |
| Shape | Cylindrical | Cylindrical |
| Diameter
Availability | 0.2mm-0.5mm | 0.2mm-0.5mm |
| Length | 2.0mm | 1.75mm |
| Packaging | Foil Pouch | Tyvek/Poly Pouch |
| Biocompatibility | Biocompatible per ISO10993 | Biocompatible per ISO10993 |
| Sterilization | EtO Sterilization | EtO Sterilization |
| Insertion
Methods | Manual with Forceps | Manual with Forceps |
| Removal
Methods | Irrigation, Probe, or Dissolution | Irrigation, Probe, or Dissolution |
Performance Data
Non-clinical performance testing for the Riverpoint Medical Absorbable Canalicular Plugs included sterilization validation per ISO11135-1:2007 - Sterilization of Health Care Products Ethylene Oxide Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices, biocompatibility testing per ISO10993-1:2009 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems, and a simulated use Usability Validation performed per EN62366: 2008-Medical devices - Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical Absorbable Canalicular Plug performed as intended.
Conclusion
Based on the information provided within this 510(k) submission, Riverpoint Medical concludes that the proposed Absorbable Canalicular Plugs do not raise significant questions of safety or effectiveness and is substantially equivalent to the predicate device.