(89 days)
Not Found
No
The summary describes a device that uses electric current for drug delivery and includes standard electrical and bench testing, with no mention of AI or ML technologies.
Yes
The device is indicated for "administration of drug solution, salts, or ions into the ear... for medical purposes", which implies a therapeutic use to treat a medical condition.
No
The device description and intended use state that it is for the administration of drug solutions, salts, or ions into the ear (therapeutic), and there is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description explicitly lists multiple hardware components: an Iontophoresis Control Unit, Iontophoresis Earsets, a Return Electrode Patch, a Syringe, and Earset Sizers. Performance studies also include bench verification testing and electrical testing, which are typical for hardware devices.
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 drug solution, salts, or ions into the ear. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The device description focuses on the mechanism of delivering substances into the ear using electric current. It doesn't mention any analysis of samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Iontophoresis System with Earset 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 Acclarent Iontophoresis System with Earset (IPSES) is a single-use device that employs electric current to transport drug solution, salts, or ions into the ear, including the tympanic membrane. The TULA Iontophoresis System consists of three components, namely an Iontophoresis Control Unit, Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSES include a Syringe and Earset Sizers. All components of the IPSES are provided non-sterile and no sterilization is required.
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)
Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance characteristics. The testing included system test, ear canal pressure and leak test, fill system burst test, plug peel force test, tack force test, and biocompatibility tests.
Electrical testing demonstrated that the subject device IPSES meets all applicable requirements of the standards of IEC 60601-1 and IEC 60601-1-2.
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.
Iontophoresis System with Headset or IPSHS (K110636)
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.
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Image /page/0/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. In the center of the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Acclarent, Inc. Pavan Sethi, PhD Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K150453
Trade/Device Name: Tula Iontophoresis System with Earset Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class III Product Code: EGJ Dated: April 21, 2015 Received: April 22, 2015
Dear Dr. Sethi:
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.
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
1
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.
Our substantially equivalent decision does not apply to the drugs that you will label or promote for use with your device. Therefore, you may neither label nor promote your device for use with specific drugs, nor package drugs with your device prior to FDA having approved the drugs for iontophoretic administration. For information on the requirements for marketing new drugs, you may contact:
Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857
As you are aware, there are concerns relating to the fact that no drug is currently labeled for administration via an iontophoresis device. The Agency currently is evaluating this public health concern regarding the safety and effectiveness of this route of administration of drugs, and in the near future will inform manufacturers of certain additional steps the Agency believes are necessary to address this concern.
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 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.
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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,
Felipe Aguel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150453
Device Name
TULA® Iontophoresis System with Earset
Indications for Use (Describe)
The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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Image /page/4/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. The first part of the word, "Acclar", is in black, while the "ent" is in a purple color. Above the word "ent" is a curved line, also in purple, that extends over the letters.
TULA Iontophoresis System with Earset
510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pavan Sethi, Ph.D.
Manager, Regulatory Affairs
Phone: (650) 687-5413
Fax: (650) 687-4847 |
| Date of Submission: | February 19, 2015 |
| Device Trade Name: | TULA® Iontophoresis System |
| Common Name: | Iontophoresis System with Earset |
| Device Classification: | Class III |
| Regulation Number: | 21 CFR 890.5525 |
| Classification Name: | Device, Iontophoresis, Other Purposes |
| Product Code: | EGJ |
| Predicate Device: | Iontophoresis System with Headset or IPSHS (K110636) manufactured by
Acclarent |
| Device Description: | The Acclarent Iontophoresis System with Earset (IPSES) is a single-use
device that employs electric current to transport drug solution, salts, or ions
into the ear, including the tympanic membrane. The TULA lontophoresis
System consists of three components, namely an Iontophoresis Control Unit,
Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSES
include a Syringe and Earset Sizers. All components of the IPSES are provided
non-sterile and no sterilization is required. |
| Indications for Use: | The Iontophoresis System with Earset is indicated for the administration of
drug solution, salts, or ions into the ear, including the tympanic membrane, for
medical purposes. |
| Technological
Characteristics: | IPSES delivers an electrical current to the ear. The electrical current transports
drug solution, salts, or ions into the ear, including the tympanic membrane. The
subject device is identical to the predicate device in method of operation and
intended use. The Iontophoresis process and the components controlling it
including Control Unit, Integrated Ear Electrode and Return Electrode Patch
are unchanged between the subject and predicate device. The main differences
in technological characteristics include, modification of the mechanism to |
| | retain the ear plug in the external ear canal and integration of ear plugs into the
design of the earset instead of being a separate accessory in the predicate
Headset device. In the predicate device, the ear plug is attached to the Headset
and retains the fluid (drug solution, salts, or ions) within the ear canal by
forming a seal. The modified device integrates this ear plug into a smaller sized
Earset to achieve an analogous seal. The predicate device uses a frame to
maintain the Headset in position and a spring to hold the ear plug in the ear
canal, whereas the modified subject device uses a small amount of soft
pressure sensitive adhesive (PSA) to secure the ear plug to the patient. These
differences in technological characteristics do not raise different questions of
safety and effectiveness than the predicate and do not render this device Not
Substantially Equivalent (NSE). |
| Performance Data: | Bench verification testing was conducted to verify that the modified device
meets the design inputs and intended performance characteristics. The testing
included system test, ear canal pressure and leak test, fill system burst test,
plug peel force test, tack force test, and biocompatibility tests. |
| | Electrical testing demonstrated that the subject device IPSES meets all
applicable requirements of the standards of IEC 60601-1 and IEC 60601-1-2. |
| Summary of
Substantial
Equivalence: | The subject device IPSES is substantially equivalent to the predicate device in
indication for use, performance, fundamental scientific technology, safety and
effectiveness. |
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Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "rent" portion in purple. A purple curved line extends over the word, adding a stylized element to the logo. The logo is simple and modern, reflecting the company's focus on innovation in the medical field.