(60 days)
The ArthroCare NasaStent is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NasaStent is constructed from absorbent CarboxyMethyl Cellulose (CMC) material.
NasaStent is a dissolvable polysaccharide intranasal splint made from plant-based CarboxyMethyl Cellulose (CMC). As it absorbs nasal fluids, it turns into a hydrocolloidal gel that naturally drains from the nasal cavity within several days.
The ArthroCare NasaStent™ CMC Nasal Dressing is a Class I device, and its 510(k) submission (K140992) indicates that no clinical studies were necessary to demonstrate its safety and effectiveness. Instead, the submission relies on bench testing to establish substantial equivalence to predicate devices.
Here's an analysis based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalency through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (conformance to ISO 10993-1) | Biocompatibility testing according to ISO 10993-1 was conducted. (Assumed to have met acceptance criteria, though no specific results are provided). |
| Packaging Validation | Packaging validation was conducted. (Assumed to have met acceptance criteria). |
| Equivalency in Resiliency to Predicate Devices | Equivalency testing with respect to resiliency was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Equivalency in Hygroscopic Characteristics to Predicate Devices | Equivalency testing with respect to hygroscopic characteristics was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Equivalency in Form Retention to Predicate Devices | Equivalency testing with respect to form retention was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Conformance to design specifications | Evaluated under a number of bench studies to assure safety, efficacy, and conformance to design specifications. (Implied that the device conformed to design specifications). |
| Substantial Equivalence to Predicate Devices (CogENT, NexPak, Nasopore) in terms of indications for use, device operation, technical and functional capabilities, design, principle of operation, and raising no new questions of safety or effectiveness. | "NasaStent shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use. Additionally, comparative performance test data demonstrated adequate device performance." "NasaStent is substantially equivalent to the predicate CogENT, NexPak, and Nasopore nasal splints in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness." |
2. Sample Size and Data Provenance (Test Set)
No clinical test set was used for this 510(k) submission. The evaluation was based entirely on bench testing. Therefore, there is no information regarding sample size for a test set or data provenance (country of origin, retrospective/prospective).
3. Number of Experts and Qualifications (Ground Truth for Test Set)
Not applicable as no clinical test set requiring expert ground truth was utilized.
4. Adjudication Method (Test Set)
Not applicable as no clinical test set was utilized.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The product is a physical device (intranasal splint), not an AI algorithm, and therefore the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used (for studies that were performed)
For the bench tests that were performed, the "ground truth" would be established by validated engineering specifications, industry standards (e.g., ISO 10993-1), and comparative performance against the established characteristics of the predicate devices. The document implies that the device met these engineering and performance benchmarks.
8. Sample Size for the Training Set
Not applicable. As a physical device evaluated via bench testing, there is no "training set" in the context of an algorithm. The "training" for the device would have been its design and manufacturing processes, which are not detailed in terms of sample sizes for this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the algorithmic sense. The design and manufacturing would be based on established engineering principles and medical needs for intranasal splints.
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510(k) Summary
JUN 1 6 2014
ArthroCare® Corporation NasaStent™
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address: | 7000 West William Cannon DriveAustin, TX 78735 |
| Contact Person: | Shannon ScottSr. Manager, Regulatory AffairsPhone: 512-358-5771Fax: 512-895-1489 |
| Date Prepared: | April 15, 2014 |
Device Name
| Proprietary Name: | ArthroCare® NasaStent™ CMC Nasal Dressing |
|---|---|
| Common Name: | NasaStent |
| Classification Name: | Intranasal splint |
| Device Class: | Class I |
| Product Code: | LYA |
| CFR Section: | 21 CFR 874.4780 |
Predicate Devices
CogENT Nasal/Epistaxis Pack Polyganics NasoPore® Nasal Dressing, Model NDOX-YYY/ZZ Hemostasis NexPak Intranasal Splint
K113585 (April 25, 2012) K052099 (November 21, 2005) Class I, Exempt
Description
NasaStent is a dissolvable polysaccharide intranasal splint made from plant-based CarboxyMethyl Cellulose (CMC). As it absorbs nasal fluids, it turns into a hydrocolloidal gel that naturally drains from the nasal cavity within several days.
Intended Use/Indications For Use
The ArthroCare NasaStent is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NasaStent is constructed from absorbent CarboxyMethyl Cellulose (CMC) material.
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Summary of the technological characteristics of the device compared to the predicate device
NasaStent shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use. Additionally, comparative performance test data demonstrated adequate device performance.
Performance Data - Summary of Non-Clinical Testing
The ArthroCare NasaStent was evaluated under a number of bench studies to assure safety, efficacy, ` conformance to design specifications and equivalence to the predicate devices. The following tests were conducted:
- 그 Biocompatibility testing according to ISO 10993-1
- . Packaging validation
- l Equivalency testing with respect to resiliency, hygroscopic characteristics and form retention
No clinical tests were necessary.
Summary
All testing conducted demonstrates that the ArthroCare NasaStent performs as intended when used in accordance with its labeling. NasaStent is substantially equivalent to the predicate CogENT, NexPak, and Nasopore nasal splints in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2014
ArthroCare Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive Austin, TX 78735
Re: K 140992
Trade/Device Name: ArthroCare® NasaStent™ CMC Nasal Dressing Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: April 15, 2014 Received: April 17, 2014
Dear Mr. Dhority:
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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Page 2 - Mr. Mitchell Dhority
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 (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" (21CFR 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/ReportalProblem/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,
Eric A. Mann -S
for Malvina B. Evdelman, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140992
Device Name ArthroCare® NasaStent™
Indications for Use (Describe)
The ArthroCare NasaStent is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NasaStent is constructed from absorbent CarboxyMethyl Cellulose (CMC) material.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
sunny.park@fda.hhs.gov 2014.06.12 20:33:42 -04'00'
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§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.