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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (PDO Absorbable Canalicular Plug) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating equivalence rather than comprehensive clinical studies with detailed acceptance criteria and performance reports in the format requested.

Therefore, the document does not contain specific acceptance criteria, detailed study results proving a device meets these criteria, sample sizes for test sets or training sets, information on expert numbers/qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily states that the device is substantially equivalent to a predicate and that "All acceptance criteria were met" for specific non-clinical performance tests. However, it does not define those acceptance criteria or report the device performance against them in a measurable way that could be tabulated as requested.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All acceptance criteria were met, and the Riverpoint Medical Absorbable Canalicular Plug performed as intended."
However, the specific acceptance criteria and the quantitative or qualitative device performance against those criteria are not detailed in this document. The document lists the types of tests performed (sterilization validation, biocompatibility, stability, usability validation) but does not provide the pass/fail thresholds or the actual results.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for any of the performance tests mentioned.
Data Provenance: The tests are non-clinical (laboratory/simulated use). Country of origin is not specified.
Retrospective/Prospective: Not applicable as these are non-clinical performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. These were non-clinical performance tests (sterilization, biocompatibility, stability, usability validation). No "ground truth" established by experts in a clinical context is described for these tests.

4. Adjudication method for the test set:

Not applicable. This relates to clinical studies and expert review, which are not detailed for the performance tests described.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

No, a MRMC comparative effectiveness study was not done according to this document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison of technological characteristics.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:

Not applicable. This device is a physical medical implant (canalicular plug), not a software algorithm.

7. Type of ground truth used:

Not applicable. The performance tests mentioned (sterilization, biocompatibility, stability, usability validation) are evaluated against established standards (e.g., ISO guidelines) and engineering specifications, not clinical "ground truth" like pathology or outcomes data.

8. Sample size for the training set:

Not applicable. There is no mention of a "training set" as this is a physical device, not an AI/machine learning model.

9. How the ground truth for the training set was established:

Not applicable. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating that a new device is "substantially equivalent" to an existing predicate device through a comparison of technological characteristics and non-clinical performance testing (e.g., sterilization, biocompatibility). It does not include the detailed clinical study information—with specific acceptance criteria, reader performances, and ground truth establishment—that would be expected for a product requiring such extensive evaluation for its primary performance claims.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K150288/S002

Device Name PDO Absorbable Canalicular Plug

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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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.

DeviceTechnologicalCharacteristic	Riverpoint Medical PDO AbsorbableCanalicular Plug	Paragon Bioteck, Inc.,Comfortear®Lacrisolve™ Absorbable PunctumPlugs (K140711)
Intended Use	The Riverpoint Medical AbsorbableCanalicular Plugs are intended to temporarilyblock tear drainage by the obstruction of thecanaliculus in the lacrimal drainage system.The Absorbable Canalicular Plugs are usedfor the temporary treatment of dry eyesyndrome, and the dry eye components ofvarious ocular surface diseases includingcontact lens intolerance secondary to dryeye. The Absorbable Canalicular Plugs canbe used in the treatment of dry eye followingocular surgery or to enhance the efficacy oftopical medicines and/or ocularlubricants. The Riverpoint MedicalAbsorbable Canalicular Plugs may also beused to determine the potential effectivenessof a non-absorbable punctal occlusion	The Comfortear® Lacrisolve™Absorbable Punctum Plugs are intendedto temporarily block tear drainage by theocclusion of the canaliculus in order to:• Determine the potential effectivenessof permanent occlusion,• Temporarily treat dry eye syndrome,and the dry eye components ofvarious ocular surface diseases,• Temporarily enhance the efficacy oftopical medications or ocularlubricants,• Temporarily treat contact lensintolerance secondary to dry eye,and• Temporarily treat dry eye after ocularsurgery

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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.

DeviceTechnologicalCharacteristic	Riverpoint Medical PDO AbsorbableCanalicular Plug	Paragon Bioteck, Inc., Comfortear®Lacrisolve™ Absorbable PunctumPlugs (K140711)
	device.
IntracanalicularPunctum Plug	Yes	Yes
IntendedDuration	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
DiameterAvailability	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
InsertionMethods	Manual with Forceps	Manual with Forceps
RemovalMethods	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.

Regulation Number and Section

N/A