Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description mentions "onboard sensors measure the tremor frequency, which is then used to customize the TAPS output pattern". This describes a calibration process based on measured data, but does not explicitly mention or imply the use of AI or ML algorithms for this customization or any other function. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

Yes.
The device description clearly states that it is "designed to aid in the temporary relief of hand tremors by applying a calibrated Transcutaneous Afferent Patterned Stimulation (TAPS)". It also mentions "delivering TAPS therapy" multiple times, directly indicating its therapeutic purpose.

Diagnostic

No

The device is described as a stimulator worn on the wrist intended for temporary relief of hand tremors by applying Transcutaneous Afferent Patterned Stimulation (TAPS). It calibrates the stimulation based on tremor frequency, but its stated purpose is therapeutic relief, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a stimulator, band with electrodes, and a base station, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cala kIQ device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Cala kIQ Function: The Cala kIQ is a stimulator device that applies electrical stimulation to nerves on the wrist. It does not analyze any biological specimens from the patient.
Intended Use: The intended use is to provide temporary relief of hand tremors through nerve stimulation, not to diagnose or provide information about a disease based on in vitro analysis.
Device Description: The description details a wearable stimulator with electrodes and sensors, not equipment for analyzing biological samples.

Therefore, the Cala kIQ falls under the category of a therapeutic or neuromodulation device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

Cala kIQ is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's Disease.

Product codes

QBC

Device Description

Cala kIQ Gen 2 is a small, lightweight, wrist-worn stimulator device designed to aid in the temporary relief of hand tremors by applying a calibrated Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist.

The TAPS output pattern is calibrated to the individual patient's tremor frequency. During device setup, the patient performs a postural hold, during which the onboard sensors measure the tremor frequency, which is then used to customize the TAPS output pattern to deliver therapy to the median and radial nerves at the appropriate, patient-specific, optimal stimulation frequency.

Cala kIQ Gen 2 is comprised of the following components:

. Stimulator: Contains sensors, electronics, and firmware for delivering TAPS therapy and provides user interface
. Band: Contains multi-use, conductive electrodes spaced at intervals to align with targeted nerves and attachment points for the Cala kIQ Gen 2 Stimulator
Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Gen 2 Stimulator contains the electronics, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Gen 2 Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Gen 2 Stimulator is attached to the Cala kIQ Gen 2 Band, which includes embedded electrodes placed at appropriate intervals to properly target the medial nerves. To accommodate a broad distribution of wrist sizes, the band is available in three sizes (small, medium, and large).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Median and radial nerves

Indicated Patient Age Range

Adults

Intended User / Care Setting

Patient / In-home use after an initial calibration in the patient's home or in the physician's office.

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)

There was no performance testing conducted in support of Cala kIQ Gen 2 premarket application.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222237

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5897 External upper limb tremor stimulator.

(a)
Identification. An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following:
(i) Characterization of the electrical stimulation, including the following, must be performed: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(ii) Impedance testing, current distribution across the electrode surface area, adhesive integrity, and shelf life testing of the electrodes and gels must be conducted.
(iii) Simulated use testing of sensor performance and the associated algorithms that determine the stimulation output must be conducted.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Instructions on how to clean the device;
(v) A shelf life for the electrodes and gel; and
(vi) Reuse information.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

November 22, 2024

Cala Health, Inc. % Amanda Johnston Regulatory Counsel for Cala Health, Inc. Gardner Law. PLLC 423 Main Street Stillwater, Minnesota 55082

Re: K242259

Trade/Device Name: Cala kIQ Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: OBC Dated: July 31, 2024 Received: July 31, 2024

Dear Amanda Johnston:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Jitendra V. Virani -S

CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242259

Device Name Cala kIQ

Indications for Use (Describe)

Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

Cala kIQ is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.

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 logo for Cala Health. The logo is in blue and features the word "CALA" in a stylized font with a swoosh above it. Below the word "CALA" is the word "HEALTH" in a smaller, sans-serif font.

510(k) Summary

I. SUBMITTER

Manufacturer:	Cala Health, Inc.
	1800 Gateway Drive, Suite 120 San Mateo, CA 94404
	Phone: (415) 890-3961
	Fax: None
Primary Contact:	Alexander Kent
	Sr. Director, Research, Cala Health, Inc.
	alex.kent@calahealth.com
	(267) 973-4180
Secondary Contact:	Amanda Johnston
	Regulatory Counsel for Cala Health, Inc.

Regulatory Counsel for Cala Health, Inc. ajohnston@gardner.law (763) 639-6951

Date Prepared: October 28, 2024

SUBJECT DEVICE II.

Trade Name:	Cala kIQTM
Regulation Name:	External upper limb tremor stimulator
Regulatory Class:	Class II
Regulation Number:	21 CFR 882.5897
Product Code:	QBC

III. PREDICATE DEVICE

Predicate Device:	Cala kIQ™
Prior Submissions:	K222237
Indications for Use:	Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor

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Cala kIQ is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.

IV. DEVICE DESCRIPTION

Cala kIQ Gen 2 is a small, lightweight, wrist-worn stimulator device designed to aid in the temporary relief of hand tremors by applying a calibrated Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist.

The TAPS output pattern is calibrated to the individual patient's tremor frequency. During device setup, the patient performs a postural hold, during which the onboard sensors measure the tremor frequency, which is then used to customize the TAPS output pattern to deliver therapy to the median and radial nerves at the appropriate, patient-specific, optimal stimulation frequency.

Cala kIQ Gen 2 is comprised of the following components:

. Stimulator: Contains sensors, electronics, and firmware for delivering TAPS therapy and provides user interface
. Band: Contains multi-use, conductive electrodes spaced at intervals to align with targeted nerves and attachment points for the Cala kIQ Gen 2 Stimulator
Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Gen 2 Stimulator contains the electronics, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Gen 2 Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Gen 2 Stimulator is attached to the Cala kIQ Gen 2 Band, which includes embedded electrodes placed at appropriate intervals to properly target the medial nerves. To accommodate a broad distribution of wrist sizes, the band is available in three sizes (small, medium, and large).

V. INDICATIONS FOR USE

Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

Cala kIQ is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's Disease.

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VI. SUBSTANTIAL EQUIVALENCE

The Subject Device of this premarket notification is Cala kIQ Gen 2 with labeling updates, utilizing Cala kIQ Gen 1 as the predicate device. Cala kIQ Gen 1 (K222237) is legally marketed as a Class II device, subject to Special Controls as per 21 CFR 882.5897. Cala kIQ Gen 2 was released under note-to-file. Both Cala kIQ Gen 1 and Gen 2 are manufactured by Cala Health, Inc.

Cala kIQ Gen 1 and Gen 2 share:

. The same intended use
The same control mechanisms, operating principles and energy type .
The same calibration algorithm and stimulation waveform .
. The same architecture of Stimulator attached to Wristband with charging Base Station

The scope of this submission is only labeling changes to the currently-released Cala kIQ (Gen 2), including the following updates to the Patient and Healthcare Professional (HCP) Guides:

Clarifying the contraindications language .
. Updating warnings and cautions
. Adding troubleshooting steps for patient convenience in resolving band connection errors
Simplifying patient instructions for accessing the Patient Portal ●

Table 1 below provides a summary comparison between the Subject Device, Cala kIQ Gen 2 with proposed labeling updates, and the Predicate Device, Cala kIQ Gen 1, with respect to intended use, technological characteristics, and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

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Table 1. Cala kIQ Substantial Equivalence

			Substantially
	Predicate Device
Cala kIQ Gen 1	Subject Device
Cala kIQ Gen 2 with proposed
labeling updates	Equivalent?
510(k) Number	K222237	This submission
Manufacturer	Cala Health	Cala Health
Intended Use
Intended Use	Delivery of transcutaneous afferent patterned
stimulation (“TAPS”) for treatment of hand
tremors	Delivery of transcutaneous afferent patterned
stimulation (“TAPS”) for treatment of hand
tremors	Yes
Subject Device is identical
to Predicate Device
Indications for Use	Cala kIQ is indicated to aid in the temporary
relief of hand tremors in the treated hand
following stimulation in adults with essential
tremor.	Cala kIQ is indicated to aid in the temporary
relief of hand tremors in the treated hand
following stimulation in adults with essential
tremor.	Yes
Subject Device is identical
to Predicate Device
	Cala kIQ is indicated to aid in the temporary
relief of postural and kinetic hand tremor
symptoms that impact some activities of daily
living in the treated hand following
stimulation in adults with Parkinson's
disease.	Cala kIQ is indicated to aid in the temporary
relief of postural and kinetic hand tremor
symptoms that impact some activities of daily
living in the treated hand following
stimulation in adults with Parkinson's
disease.
Target Population	Adults with essential tremor or Parkinson's
Disease	Adults with essential tremor or Parkinson's
Disease	Yes
Subject Device is identical
to Predicate Device
Anatomical site	Median and radial nerves	Median and radial nerves	Yes
Subject Device is identical
to Predicate Device
Intended Users	Patient	Patient	Yes
Subject Device is identical
to Predicate Device
	Predicate Device
Cala kIQ Gen 1
K222237	Subject Device
Cala kIQ Gen 2 with proposed
labeling updates	Substantially
Equivalent?
Clinical Setting	In-home use after an initial calibration in the
patient's home or in the physician's office.	In-home use after an initial calibration in the
patient's home or in the physician's office.	Yes
Subject Device is identical
to Predicate Device
Rx or OTC use	Prescription Use only	Prescription Use only	Yes
Subject Device is identical
to Predicate Device
Design
Technology	Transcutaneous Afferent Patterned
Stimulation (TAPS) delivered through
electrodes embedded on wearable band	Transcutaneous Afferent Patterned
Stimulation (TAPS) delivered through
electrodes embedded on wearable band	Yes
Subject Device is identical
to Predicate Device
Energy used or
delivered	Electrical stimulation	Electrical stimulation	Yes
Subject Device is identical
to Predicate Device
Human Factors	Wrist-worn electrical stimulator with
detachable band containing multi-use
electrodes. Base station provides charging
function and contains indicator lights for
operating status	Wrist-worn electrical stimulator with
detachable band containing multi-use
electrodes. Base station provides charging
function and contains indicator lights for
operating status	Yes
Subject Device is identical
to Predicate Device
Patient Contacting
Materials	The following components of the Cala kIQ
Band have Surface, Intact Skin Long-Term
contact (>30 days):
Elastic (polyester)Electrodes (silicone with carbon
nanotube dispersion)Microfiber (polyurethane and nylon)Elastic (nylon with spandex)Band thread (polyester)	The following components of the Cala kIQ Band
have Surface, Intact Skin Long-Term contact
(>30 days):
Electrodes (silicone with carbon
nanotube dispersionElastic (polyester with spandex)Band thread (cotton)Band silicone bodyBand hook (sabic PC/ABS)Stimulator bottom (PC/ABS)	Yes
All patient-contacting
materials are
biocompatible per ISO-

The electrode
material is unchanged
from the predicate device. |
| | Predicate Device
Cala kIQ Gen 1
K222237 | Subject Device
Cala kIQ Gen 2 with proposed
labeling updates | Substantially
Equivalent? |
| Operating Principle | Transcutaneous Afferent Patterned
Stimulation (TAPS) to the median and
radial nerves of a patient's wrist | Transcutaneous Afferent Patterned
Stimulation (TAPS) to the median and radial
nerves of a patient's wrist | Yes
Subject Device is identical
to Predicate Device |
| Electrodes | 6
Individual Electrode Surface area
22mm x 6mm = 1.32 cm² | 6
Individual Electrode Surface area
22mm x 6mm = 1.32 cm² | Yes
Subject Device is identical
to Predicate Device |
| Battery and Base
Station | Rechargeable Lithium-ion battery and AC-
powered charger. | Rechargeable Lithium-ion battery and AC-
powered charger. | Yes
Subject Device is identical
to Predicate Device |
| Performance | | | |
| User Workflow | 1. Calibration
Set stimulation intensity
Therapy available on demand | 1. Calibration
Set stimulation intensity
Therapy available on demand | Yes
Subject Device is identical
to Predicate Device |
| Treatment Time | 40 minutes | 40 minutes | Yes
Subject Device is identical
to Predicate Device |
| Wristband life | 90 days | 90 days | Yes
Subject Device is identical
to Predicate Device. |
| | Predicate Device
Cala kIQ Gen 1
K222237 | Subject Device
Cala kIQ Gen 2 with proposed
labeling updates | Substantially
Equivalent? |
| Shelf-life | Cala kIQ Band: 3 months | Cala kIQ Band: 18 months | Yes
Increased shelf-life is due
to availability of test data,
not from changes in
performance or safety
characteristics |
| Output Specifications | | | |
| Waveform (e.g.,
pulsed monophasic,
biphasic) | Biphasic | Biphasic | Yes
Subject Device is identical
to Predicate Device |
| Shape (e.g.,
rectangular, spike,
rectified sinusoidal) | Rectangular | Rectangular | Yes
Subject Device is identical
to Predicate Device |
| Maximum Output
Voltage
(volts) | 4 @ 500Ω

80 @ 10kΩ | 4 @ 500Ω

80 @ 10kΩ | Yes
Subject Device is identical
to Predicate Device |
| Maximum Output
Current
(mA) | 8 @ 500Ω

8 @ 10kΩ | 8 @ 500Ω

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PERFORMANCE DATA VII.

There was no performance testing conducted in support of Cala kIQ Gen 2 premarket application.

VIII. CLINICAL DATA

There was no clinical testing conducted in support of Cala kIQ Gen 2 premarket application.

IX. SUBSTANTIAL EQUIVALENCE

Substantial equivalence of the Subject Device, Cala kIQ Gen 2 with proposed labeling updates, to the Predicate Device, Cala kIQ Gen 1, is demonstrated based on the comparison of labeling, technical characteristics, performance, and testing.

The intended use and indications for use are unchanged.

The performance data reviewed in previous submissions, including the predicate submission, are still applicable to the subject device since they are similar in technology, and, hence, the previously reviewed data supports that the subject device meets special controls.

X. CONCLUSION

The Subject Device, Cala kIQ Gen 2 with labeling updates, has the same intended use and indications for use as the Predicate Device, Cala kIQ Gen 1. The subject and predicate device have similar technological characteristics and the differences do not raise new questions of safety or effectiveness.

Cala kIQ Gen 2 and Cala kIQ Gen 1 are substantially equivalent. Cala Health has provided evidence as described above to demonstrate that any differences in the technological characteristics do not impact safety or effectiveness.