(88 days)
The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).
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 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 upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.
ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.
I am sorry, but the provided text from the K974855 submission does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) summary and the FDA's response letter for the Phoresor® II, Model PM900 iontophoresis device. It focuses on:
- Device Description and Intended Use: Explaining what the device is and its purpose (administration of soluble salts or other drugs into the body for medical purposes, specifically local dermal anesthesia using Iontocaine™).
- Predicate Device: Identifying the previous model (Phoresor® II, Model PM800) for substantial equivalence comparison.
- Regulatory Classification: Discussing the classification of iontophoresis devices (Class II or Class III) and the conditions under which the PM900 is considered substantially equivalent.
- FDA's Decision: Confirming the device's substantial equivalence to devices marketed prior to May 28, 1976, provided it complies with regulations, particularly regarding drug labeling and manufacturing practices. The approval specifically applies to the use with Iontocaine™.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, or the nature of any study dataset.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and ground truth establishment as might be seen for novel high-risk medical devices or AI-powered diagnostics. In this case, the updated device (PM900) is being compared to its predecessor (PM800), and the focus is on its intended use for drug delivery, not diagnostic performance.
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510(K) SUMMARY
Date: December 22, 1997
MAR 2 7 1998
Submitter:
IOMED, Inc. 3385 West 1820 South Salt Lake City UT 84104 Tel: (801) 975-1191 Fax: (801) 972-9072
Contact:
W. Tim Miller Executive Vice President General Manager, Clinical Systems
Device Name:
Iontophoresis Device Iontophoretic Device Modification Phoresor® II, Model PM900
Predicate Device:
Iontophoresis Device Phoresor® II , Model PM800 K934335
Description of Device:
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 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 upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.
ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.
Intended Use of Device:
Indications for use of the predicate and modified Phoresor® II iontophoretic drug delivery device are identical. This modified device is intended to be used for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle insertion and drug injection; when it is advisable to minimize the infiltration of carrier fluids; to avoid the damage caused by needle insertion when tissue is traumatized. It is Iso indicated for production of local dermal anesthesia using Iontocaine™, brand of Lidocaine HCl 2% and Epinephrine 1:100,000.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 1998
Mr. W. Tim Miller Executive Vice President Iomed, Inc. 3385 West 1820 South Salt Lake City, Utah 84104
Re: K974855 Phoresor® II Model PM 900 Requlatory Class: II Product Code: KTB December 22, 1997 Dated: December 29, 1997 Received:
Dear Mr. Miller
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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), as long as you comply with all of the Act's requirements relating to drugs labeled or promoted with the devices as described below. This substantially equivalent decision applies only to the use of your device for iontophoretic dermal delivery of Iontocaine™ 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 practices, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,
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Page 2 - Mr. W. Tim Miller
through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
Our substantially equivalent decision does not apply to drugs other than Iontocaine that you might 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 Druq Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland
As you are aware, iontophoresis devices that are 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 druq, were classified into Class II. An iontophoresis device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes other than those specified for class II devices is classified into Class III (21 CFR 890.5525). We published our strategy for calling for premarket approval (PMA) applications in the Federal Register, dated May 6, 1994, and the . enclosed enclosed memorandum, dated April 19, 1994.
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Page 3 - Mr. W. Tim Miller
If you have any questions regarding this letter, you may contact :
Kevin Lee, M. D. Division of General and Restorative Device Office of Device Evaluation 9200 Corporate Boulevard Rockville, MD 20850 Tel (301) 594-1296
This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and permits your devices 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 (301) 594-4659 . Additionally, for question on the promotion and advertising, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D. , M. D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Statement of
INDICATIONS FOR USE
The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).
P. Costello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974855
Prescription Use
X
(Per 21 CFR 801.109)
IOMED, Inc. 510(k) # K974855 Revised Page 007 February 19, 1998
§ 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.