Orchid Safety Release Valve(TM)

K212064 · Linear Health Sciences, LLC · QOI · May 3, 2022 · General Hospital

Device Facts

• Record ID: K212064
• Device Name: Orchid Safety Release Valve(TM)
• Applicant: Linear Health Sciences, LLC
• Product Code: QOI · General Hospital
• Decision Date: May 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5220
• Device Class: Class 2

Indications for Use

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent and continuous infusion. The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. The Orchid SRV™ is for use with patients eighteen (18) years of age and older.

Device Story

The Orchid Safety Release Valve (SRV) is a single-use, tension-activated accessory placed between an IV administration set and an IV extension set. It uses standard luer-locking connections to maintain a continuous fluid path during normal operation. When longitudinal tension on the IV tubing exceeds a specific threshold (1-4.2 lbf), the device mechanically separates into two halves. Upon separation, internal valves automatically close the flow path in both directions to prevent fluid leakage and blood loss. The device is used in hospital settings by clinicians to prevent peripheral IV catheter dislodgement. By separating before the catheter is pulled from the vein, the device reduces mechanical complications and the need for IV replacement, particularly in patients with fragile skin or those at high risk of dislodgement.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including usability testing, functional testing (tensile strength, leakage, flow rate, re-assembly prevention), luer lock testing, microbial ingress testing, and clinical simulation testing. Biocompatibility was evaluated per ISO 10993-1.

Technological Characteristics

Tension-activated mechanical separation device; luer-locking connections; separation force 1-4.2 lbf. Materials evaluated per ISO 10993-1. Sterilized via Ethylene Oxide (SAL 10^-6). Standards: ISO 8536-4, ISO 80369-20, ISO 80369-7, USP <788>, ASTM D4169, ASTM F88, ASTM F1886, ASTM F2069, ASTM F1980, AAMI TIR28, ISO 14937.

Indications for Use

Indicated for patients 18+ years old receiving intermittent or continuous IV infusion via electronic pumps through peripheral IV catheters, to reduce mechanical complications requiring catheter replacement.

Regulatory Classification

Identification

An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.

Special Controls

In combination with the general controls of the FD&C Act, intravenous catheter force-activated separation device is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Separation force testing; (ii) Validation of anti-reconnect features; (iii) Air and liquid leakage testing, both before and after separation; (iv) Luer connection testing; (v) Flow rate testing; (vi) Particulate testing; and (vii) Microbial ingress testing. (3) The device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate that the device is sterile and non-pyrogenic. (5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (6) Device labeling must include: (i) Instructions for use; and (ii) A discussion of catheter dressings intended to be used with the device.

Predicate Devices

• SafeBreak® Vascular (DEN190043)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Linear Health Sciences, LLC % Jessica Czamanski Project Engineer RQM+ 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146

# Re: K212064

Trade/Device Name: Orchid Safety Release Valve™ Regulation Number: 21 CFR 880.5220 Regulation Name: Intravenous Catheter Force-Activated Separation Device Regulatory Class: Class II Product Code: QOI Dated: March 8, 2022 Received: March 9, 2022

# Dear Jessica Czamanski:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212064

Device Name Orchid Safety Release Valve(TM)

#### Indications for Use (Describe)

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRVTM is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRVTM is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRVTM separates and closes the flow path in both directions. The Orchid SRVTM can be used during intermittent and continuous infusion.

The Orchid SRVTM is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients eighteen (18) years of age and older.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is in blue and gray. The word "LINEAR" is in blue, and the words "HEALTH SCIENCES" are in gray and are located below the word "LINEAR". There is a trademark symbol to the right of the word "LINEAR".

# 510(k) SUMMARY

# K212064

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.

#### Submitter l.

| Submitter's Name: | Linear Health Sciences, LLC |
|-------------------|------------------------------------------------|
| Contact Person: | Mr. Daniel Clark<br>President |
| Address: | 5333 Wisteria Drive Oklahoma<br>City, OK 73142 |
| Telephone: | [phone] |
| Email: | [e-mail] |
| Date Preparation: | April 4, 2022 |

#### II. Application Correspondent

| Contact's Name: | RQM+ |
|-----------------|--------------------------------------------------------------|
| Contact Person: | Jessica Czamanski<br>Project Engineer, Regulatory Consultant |
| Address: | 2790 Mosside Blvd #800<br>Monroeville, PA 15146 |
| Telephone: | [phone] |
| Email: | [e-mail] |

# III. Subject Device

| Trade Name: | Orchid Safety Release Valve™ |
|-------------------------|--------------------------------------------------------|
| Common Name: | Quick Disconnect Accessory |
| Classification Name: | Intravenous Catheter Force-Activated Separation Device |
| Product Classification: | Class II |
| Regulation Number: | 21 CFR §880.5220 |
| Product Code: | QOI |

# IV. Predicate Device

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Image /page/4/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is written in blue, with the "I" in "LINEAR" being stylized as a vertical line with a small square on top. Below "LINEAR" is the text "HEALTH SCIENCES" in gray. To the right of the word "LINEAR" is the trademark symbol.

| Manufacturer: | Site Saver, Inc. d/b/s Lineus Medical |
|-------------------------|----------------------------------------|
| Device Name: | SafeBreak® Vascular |
| 510(k) Number: | DEN190043 |
| Product Classification: | Class II |
| Regulation Number: | 21 CFR §880.5220 |

## V. Device Description

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window (between 1-4.2 lbf), automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

### VI. Intended Use

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory, provided sterile and for single use, in line with an IV administration set and peripheral IV extension set on a patient. The Orchid SRV™ provides a quick separation feature that allows the device to quickly separate into two halves upon tension, closing the flow path to prevent leakage. The device is intended to reduce the risk of IV catheter failure, requiring IV catheter replacement.

### VII. Indications for Use

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.

The Orchid SRV™ is for use with patients eighteen (18) years of age and older.

### VIII. Comparison of Technological Characteristics with the Predicate Devices

The subject and predicate devices are accessories that allow separation by force-activation used in infusion and/or IV administration. Both devices are intended to be connected via standard luer lock mechanisms. Both devices have intended use, same material types, similar technological characteristics, and same operating principle. Although the difference in technological characteristics is specific to the force required for separation of the two halves of each device performs according to its own specifications. Both devices are intended to aid in reduction of the occurrence of dislodgement, therefore, the difference in technology do not affect the safety and effectiveness of the device and is substantially equivalent.

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Image /page/5/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is blue and consists of the word "LINEAR" in large, bold letters, with a small "TM" symbol in the upper right corner. Below the word "LINEAR" are the words "HEALTH SCIENCES" in smaller, gray letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.

The following table (Table 5-1) provides an overview of general technological characteristics in comparison to the predicate device.

| Product<br>Features | Subject<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K212064) | Predicate<br>Site Saver, Inc./ Lineus<br>Medical<br>SafeBreak Vascular<br>(DEN190043) | Substantial<br>Equivalence<br>Determination |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | -same- | |
| Product Code | QOI | -same- | |
| Regulation<br>Number | 21 CFR §880.5220 | -same- | |
| Device<br>Classification<br>Name | Intravenous Catheter<br>Force-Activated<br>Separation Device | -same- | |
| Indications for<br>Use | The Linear Health<br>Sciences™ Orchid Safety<br>Release Valve™ is a<br>tension-activated<br>accessory for single<br>patient use and placed<br>between the existing IV<br>administration set and IV<br>extension set connection.<br>The Orchid SRV™ is<br>intended for use with<br>electronic IV pumps in<br>peripheral IV catheter<br>applications where tension<br>may act on the IV tubing.<br>The Orchid SRV™ is<br>designed to allow flow to<br>an IV catheter. When<br>excessive tension acts on<br>the line, the Orchid SRV™<br>separates and closes the<br>flow path in both<br>directions. The Orchid<br>SRV™ can be used during<br>intermittent infusion and<br>continuous infusion.<br>The Orchid SRV™ is<br>intended to aid in<br>reduction of peripheral IV<br>mechanical complications<br>requiring IV replacement.<br>The Orchid SRV™ is for<br>use with patients eighteen<br>(18) years of age and<br>older. | SafeBreak® Vascular is<br>intended to separate<br>when excessive tension<br>is exerted across a<br>peripheral IV<br>administration set. When<br>SafeBreak® Vascular<br>separates, fluid flow is<br>stopped from the<br>infusion pump and blood<br>flow is stopped from the<br>patient's IV catheter.<br>SafeBreak® Vascular is<br>intended to aid in<br>reduction of peripheral<br>IV mechanical<br>complications requiring<br>IV replacement.<br>SafeBreak® Vascular is<br>intended to be used on<br>peripheral IV catheters<br>in adults and adolescent<br>populations eighteen<br>(18) years of age and<br>older receiving<br>intermittent or<br>continuous infusions<br>with an electronic pump. | The subject and<br>predicate devices<br>are intended to<br>reduce<br>dislodgement<br>during IV infusion.<br>However, the<br>Orchid SRV has a<br>lower separation<br>force, which allows<br>the device to<br>prevent<br>dislodgement when<br>using securement<br>methods that have<br>lower pull forces. |
| Table 5-1: General Technological Characteristics Comparison | | | |
| Product<br>Features | Subject<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K212064) | Predicate<br>Site Saver, Inc./ Lineus<br>Medical<br>SafeBreak Vascular<br>(DEN190043) | Substantial<br>Equivalence<br>Determination |
| Environment of<br>Use | Hospital | -same- | |
| Provided Sterile | Yes | -same- | |
| Principle of<br>Operation | The Orchid Safety<br>Release Valve™ has luer<br>lock connections that will<br>lock the device in place<br>during use. The female<br>luer connects to an<br>administration set while<br>the male luer connects to<br>a vascular access device<br>hub or extension set. Once<br>connected the device<br>allows for continuous flow.<br>The Orchid SRV will<br>separate into the male and<br>female subassemblies,<br>upon a tension event,<br>automatically closing the<br>flow path, while<br>maintaining sterility and<br>preventing fluid leakage<br>form the device. | The SafeBreak Vascular<br>connects to the<br>needleless connector<br>found in the existing IV<br>extension set and to the<br>existing IV<br>administration set via<br>luer connectors. Upon<br>installation of the<br>SafeBreak Vascular,<br>infusion can occur. Upon<br>tension the SafeBreak<br>Vascular separates and<br>the valve on each end of<br>the device closes,<br>stopping flow. | The principle of<br>operation for the<br>subject and<br>predicate devices is<br>the same. |
| User Profile | Physician or clinical<br>personnel with clearance<br>to administer IV sets and<br>related products | -same- | |
| Separation<br>Force | 1-4.2 lbf | 4 ± 1 lbf | The lower limit of the<br>Orchid Safety<br>Release Valve's<br>separation force of 1-<br>4.2 lbf was<br>specifically designed<br>to provide subject<br>device separation<br>prior to securement<br>device failure even for<br>those securement<br>devices that come in<br>at the lower end of<br>the pull force<br>spectrum. Some<br>medical adhesives<br>are specifically<br>formulated to require<br>a lower pull force due<br>to the usage on<br>elderly, fragile skin, or |
| | | | those at risk of<br>increased IV<br>dislodgement. The<br>Orchid SRV's use<br>specifications that<br>work across the low<br>end of the range<br>provide benefit to<br>these patients.<br>Performance<br>testing performed<br>to demonstrate<br>that device<br>conforms to<br>specification. |
| Vascular access<br>Catheter Type | Peripheral catheter | -same- | |
| For Use with<br>Electronic<br>Pump | Yes | -same- | |
| Single Use | Yes | -same- | |
| Continuous and<br>Intermittent<br>Infusion | Yes | -same- | |

# Table 5-1: General Technological Characteristics Comparison

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Image /page/6/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font, with a small "TM" symbol in the upper right corner. Below "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is blue and consists of the word "LINEAR" in large, bold letters, with the "I" in "LINEAR" replaced by a vertical line. Below the word "LINEAR" are the words "HEALTH SCIENCES" in smaller, gray letters. There is a trademark symbol to the right of the word "LINEAR".

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Image /page/8/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font, with a small trademark symbol in the upper right corner. Below the word "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font.

| Product<br>Features | Subject<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K212064) | Predicate<br>Site Saver, Inc./ Lineus<br>Medical<br>SafeBreak Vascular<br>(DEN190043) | Substantial<br>Equivalence<br>Determination |
|---------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Sterilization | Ethylene Oxide | -same- | |
| SAL | $10^{-6}$ | -same- | |

### IX. Performance Data

The following performance data was considered in support of the substantial equivalence determination.

The following tests were performed to demonstrate that the proposed Orchid Safety Release Valve™ met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.

### Performance Testing

- Usability Testing ●
- Functional Testing:
- o Tensile Strength Testing (ISO 8536-4 A-3)
- Air Leakage Device Not Activated (ISO 80369-20:2015 Annex D) O
- Force to Disconnect O
- Air Leakage Device Activated (ISO 80369-20:2015 Annex D) O
- Water Leakage Device Not Activated (ISO 80369-20:2015 Annex C) O
- Water Leakage Female (ISO 80369-20:2015 Annex C) O
- Water Leakage Male (ISO 80369-20:2015 Annex C) o
- Flow Rate O
- Re-assembly Prevention o
- Assembly Weight O
- Particulate Testing (USP <788>)
- Luer Lock Testing (ISO 80369-7:2016)
- Microbial Ingress Testing ●
- . Clinical Simulation Testing

#### Sterilization

.

The Orchis SRV is provided sterile and is sterilized with Ethylene Oxide. The following testing was performed:

- Packaging and Sterilization Testing (ASTM D4169-16, ASTM F88/F88M-15, ASTM ● F1886/F1886M-16, ATM F2069-11)
- Shelf-Life Testing (ASTM F1980-16)
- Bacterial Endotoxin Testing .

The sterilization validation followed the guidelines in the Product Adoption and Process Equivalence for Ethylene Oxide Sterilization AAMI TIR28:2016. The sterilization process has been validated per ISO 14937:2009 using the half dose method. The overkill approach was used to ensure a sterility assurance level (SAL) of 10-6 was achieved.

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Image /page/9/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font, with a small "TM" symbol in the upper right corner. Below "LINEAR" in a smaller, gray, sans-serif font are the words "HEALTH SCIENCES."

### Biocompatibility

Biocompatibility testing was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

The proposed Orchid Safety Release Valve™ is considered an externally communicating, prolonged exposure device that indirectly contacts the blood path. Therefore, the following tests are required:

- Cytotoxicity (ISO 10993-5:2009) ●
- . Sensitization (ISO 10993-10:2010)
- Irritation/Intracutaneous Reactivity (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
- Material-Mediated Pyrogenicity (ISO 10993-11:2017) .
- Subacute/Subchronic Toxicity (ISO 10993-11:2017) ●
- Haemocompatibility (ISO 10993-4:2017) .

Based on the results of the biocompatibility testing performed on the final Orchid Safety Release Valve™, the SRV meets the requirements outlined in ISO 10993-1:2018.

## X. Conclusion

The proposed Orchid Safety Release Valve™ has the same intended use, environment of use, operating principle and fundamental technology, and similar materials as the predicate device. Any differences in the technological characteristics do not raise any new questions or concerns of safety and effectiveness. The information provided in this submission demonstrates that the subject device is substantially equivalent to its predicate.