(105 days)
Not Found
No
The summary describes a device that uses electric current for drug delivery and lists standard electrical components. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
The device is used for the "administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes," which is a therapeutic function.
No
The device description states its purpose is to "transport drug solution, salts, or ions in the ear," which implies a therapeutic or drug delivery function rather than diagnosing a condition.
No
The device description explicitly lists multiple hardware components (Control Unit, Ear Electrodes, Electrode Cable, Ear Plugs, Return Electrode, and Fill Nozzle) that are part of the Iontophoresis System.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the administration of substances into the ear for medical purposes. This is a therapeutic or drug delivery function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system for applying electric current to transport substances. This aligns with a therapeutic or drug delivery device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Iontophoresis System is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
The Iontophoresis System (IPS) is a single-use device that employs electric current to transport drug solution, salts, or ions in the ear, including the tympanic membrane. The Iontophoresis System consists of 6 accessories: Control Unit, Ear Electrodes, Electrode Cable, Ear Plugs, Return Electrode, and Fill Nozzle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, including the tympanic membrane
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)
The Iontophoresis System met all performance testing acceptance criteria.
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
§ 890.5525 Iontophoresis device.
(a)
Iontophoresis device intended for certain specified uses —(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.
0
Image /page/0/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line extends from the top of the "l" in "Acclarent" and arches over the word, ending near the "t". The logo is simple and modern.
Iontophoresis System
Traditional 510(k)
MAR=5 2008
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen
Regulatory Affairs Specialist
Phone: (650) 687-5874
Fax: (650) 687-4449 |
| Date of Submission: | February 1, 2008 |
| Device Trade Name: | TBD |
| Common Name: | lontophoresis System |
| Device Classification: | Class III |
| Regulation Number: | 21 CFR 890.5525 |
| Classification Name: | Device, Iontophoresis, Specific Uses |
| Product Code: | EGJ |
| Predicate Devices: | 1. Ionesthetizer (K884834) manufactured by Xomed
2. Model 6110C Otophor (K870272) manufactured by Life-Tech. |
| Device Description: | The Iontophoresis System (IPS) is a single-use device that employs electric
current to transport drug solution, salts, or ions in the ear, including the
tympanic membrane. The Iontophoresis System consists of 6 accessories:
Control Unit, Ear Electrodes, Electrode Cable, Ear Plugs, Return Electrode,
and Fill Nozzle. |
| Indications for Use: | The lontophoresis System is indicated for the administration of drug
solution, salts, or ions into the ear, including the tympanic membrane, for
medical purposes. |
| Technological
Characteristics | The Iontophoresis System generates an electrical current in the ear. The
electrical current transports drug solution, salts, or ions in the ear, including
the tympanic membrane. |
| Performance Data | The Iontophoresis System met all performance testing acceptance criteria. |
| Summary of
Substantial
Equivalence: | The Iontophoresis System is substantially equivalent to the predicate devices
as confirmed through relevant performance tests. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2001
Acclarent Inc. c/o Ms. Keri Yen 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K073276 Trade Name: Iontophoresis System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device, Other Uses Regulatory Class: Class III Product Code: EGJ Dated: February 1, 2008 Received: February 4, 2008
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.
2
Page 2 - Ms. Keri Yen
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line appears above the "ent" portion of the word, creating a visual accent. The text is black against a white background.
Iontophoresis System
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K073276
TBD Trade Name:
Common Name: Iontophoresis System
Indications For Use:
The Iontophoresis System is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
Prescription Use X (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)
Neil R.P. Ogden for ARA
Page 1 of 1
Division of General, Restorative, and Neurological Devices
(Posted November 13, 2003)
510(k) Number K073276