(30 days)
Not Found
No
The description focuses on basic microprocessor control for current delivery and does not mention any AI/ML algorithms or capabilities.
Yes
The device is described as administering soluble salts or other drugs into the body for medical purposes, which directly indicates a therapeutic function.
No
The device is described as an "iontophoresis device" intended for "administration of soluble salts or other drugs into the body for medical purposes." It delivers drugs using electrical current and does not mention any diagnostic capabilities.
No
The device description explicitly details hardware components, including a transdermal patch and a dose controller, which is a battery-powered, microprocessor-controlled device delivering electrical current. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections." This describes a therapeutic or drug delivery function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on using electrical current to introduce substances into the body through the skin. This is a method of drug delivery, not a method of analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hybresis system'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 Hybresis system is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.
The Empi Hybresis integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, one-application use and can only be used with Empi's Hybresis dose controller. The Hybresis dose controller provides control of the current and therefore dosage delivered.
The Hybresis dose controller is a small, battery-powered, microprocessor-controlled Iontophoresis device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical Testing:
Verification of the Hybresis includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Hybresis includes testing to show the device meets user needs according to marketing requirements.
Clinical Testing:
No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Hybresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence. The Product does not fit the profile of devices that might require clinical data per FDA guidance document 95-4158.
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/1 description: The image shows a handwritten alphanumeric string. The string appears to be "K072946". The characters are written in a cursive style, with varying stroke thicknesses. The background is plain white.
Hybresis 510(k) Submission V01.00
510(k) Summary
| 510(k) Owner's Name: | Empi, Inc. |
|---|---|
| Address: | 599 Cardigan Rd. St. Paul, MN 55126 |
| Phone number: | 651-415-7344 |
| Fax number: | 651-415-7497 |
| Email: | swalrod@empi.com |
| Contact person: | Sandra Walrod, Regulatory Affairs Associate |
| Date prepared: | October 16, 2007 |
| Trade name: | Hybresis Iontophoresis Drug Delivery System |
| Common name: | Iontophoresis Device |
| Classification name: | Iontophoresis Device (21 CFR 890.5525) |
| Product Code: | EGJ |
| Classification: | III |
| Predicate device(s): | Champion Iontophoresis Drug Delivery System K063465 February 28, 2007 |
NOV 1 6 2007#### Device Description:
An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.
The Empi Hybresis integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, one-application use and can only be used
1
with Empi's Hybresis dose controller. The Hybresis dose controller provides control of the current and therefore dosage delivered.
The Hybresis dose controller is a small, battery-powered, microprocessor-controlled Iontophoresis device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.
Intended Use:
Iontophoresis drug delivery devices are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
Comparison to predicate:
The reason for this Special 510(k) submission, device modification, is for Empi to receive a clearance letter with the Hybresis Iontophoresis Drug Delivery System name and to inform FDA of the addition of two contraindications to the Hybresis IFU. The original 510(k) clearance letter is the Champion Iontophoresis Drug Delivery System, K063465, February 28, 2007.
Also, this submission is intended to demonstrate that the Hybresis has the same intended use as the predicate device and that there are no changes to the fundamental scientific technology and the basic considerations described in the guidance.
Non-clinical Testing:
Verification of the Hybresis includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Hybresis includes testing to show the device meets user needs according to marketing requirements.
Clinical Testing:
No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Hybresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence. The Product does not fit the profile of devices that might require clinical data per FDA guidance document 95-4158.
Conclusion:
The Empi Hybresis is substantially equivalent the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines or strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Empi, Inc. % Ms. Sandra Walrod Regulatory Affairs Associate 599 Cardigan Road St. Paul. MN 55126
Re: K072946
Trade/Device Name: Hybresis Iontophoresis Drug Delivery System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: Class III Product Code: EGJ Dated: October 30, 2007 Received: November 2, 2007
Dear Ms. Walrod:
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.
3
Page 2 - Ms. Sandra Walrod
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Hybresis Iontophoresis Drug Delivery System
Indications for Use:
The Hybresis system is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
Prescription Use ___ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| Confidential | Page 21 of 34 |
| 510(k) Number | K072946 |