(44 days)
To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
The Sinus Balloon Catheter—Integrated Wire is a sinus balloon catheter that has an integrated guidewire. The Sinus Balloon Catheter—Integrated Wire allows access to and dilation of the sinus ostia and paranasal spaces with a single device.
The provided text describes a medical device, the "Sinus Balloon Catheter—Integrated Wire," and its 510(k) submission to the FDA. However, the document does not contain the specific details required to complete your request regarding acceptance criteria and the study that proves the device meets them.
The relevant section only states:
"The Sinus Balloon Catheter—Integrated Wire met all performance testing acceptance criteria."
And:
"The Sinus Balloon Catheter—Integrated Wire is substantially equivalent to the predicate devices as confirmed through relevant performance tests."
This indicates that performance testing was conducted and acceptance criteria were met, but the document does not elaborate on:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Whether a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
Therefore, I cannot provide the requested information based on the given text. This document is a summary of the 510(k) process and regulatory filing, not likely to contain detailed performance study protocols and results. Such details would typically be in an accompanying technical report or design validation documentation, which is not included here.
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:
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 | AUG 18 2006 |
|---|---|---|
| Contact Person: | Keri YenQuality EngineerPhone: (650) 687-5874Fax: (650) 687-5889 | |
| Date of Submission: | June 30, 2006 | |
| Device Trade Name: | To be determined | |
| Common Name: | Sinus Balloon Catheter—Integrated Wire | |
| Device Classification: | Class I | |
| Regulation Number: | 21 CFR 874.4420 | |
| Classification Name: | ENT Manual Surgical Instrument | |
| Product Code: | LRC | |
| Predicate Device: | Relieva Sinus Balloon Catheter (K043527)Relieva Sinus Guidewire (K043445) | |
| Device Description: | The Sinus Balloon Catheter—Integrated Wire is a sinus balloon catheter thathas an integrated guidewire. The Sinus Balloon Catheter—Integrated Wireallows access to and dilation of the sinus ostia and paranasal spaces with asingle device. | |
| Indications for Use: | To provide a means to access the sinus space and to dilate the sinus ostia andspaces within the paranasal sinus cavities for diagnostic and therapeuticprocedures. | |
| TechnologicalCharacteristics | The Sinus Balloon Catheter—Integrated Wire is a device that allows for thecapability to access and to dilate the sinus ostia with the same device. | |
| Performance Data | The Sinus Balloon Catheter—Integrated Wire met all performance testingacceptance criteria. | |
| Summary ofSubstantialEquivalence: | The Sinus Balloon Catheter—Integrated Wire is substantially equivalent to thepredicate devices as confirmed through relevant performance tests. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
Acclarent, Inc. c/o Keri Yen Quality Assurance Engineer 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K061903
Trade/Device Name: Sinus Balloon Catheter – Integrated Wire Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: July 31, 2006 Received: August 1, 2006
Dear Ms. Yen:
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.
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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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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychlenis IWD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nosc and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sinus Balloon Catheter-Integrated Wire
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name:
To be determined
Common Name:
Sinus Balloon Catheter--Integrated Wire
Indications For Use:
To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
on of Ophthalmic Ear.
510(k) Number K061903
Page / of /
(Posted November 13, 2003)
Prescription Use (Per 21 CFR 801.109)
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(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 § 874.9.