Promisemed Safety Huber Needle

K230715 · Promisemed Hangzhou Meditech Co., Ltd. · PTI · Jun 8, 2023 · General Hospital

Device Facts

• Record ID: K230715
• Device Name: Promisemed Safety Huber Needle
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: PTI · General Hospital
• Decision Date: Jun 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Device Story

Safety Huber Needle is a sterile, single-use, non-coring intravascular infusion set designed for accessing surgically implanted vascular ports. It features a right-angle Huber needle, integrated extension tubing, Y-injection site, clamp, and female Luer lock adapter. A manually activated safety mechanism sheathes the needle upon removal to prevent needlestick injuries. The device is operated by clinicians in a clinical setting. High-pressure resistant models support power injection of contrast media up to 330 psi for CT imaging. The device remains on the patient for 24 hours to 7 days. By providing a secure infusion path and a sharps-protection mechanism, the device facilitates drug/fluid delivery and contrast administration while minimizing clinician risk of accidental injury.

Clinical Evidence

Bench testing only. Performance verified via ISO 8536-4, ISO 80369-7, ISO 23908, ISO 9626, ISO 7864, ANSI/AAMI CN27, and ASTM F3212-16. Biocompatibility validated per ISO 10993-1, -3, -4, -5, -6, -7, -10, -11. Sterilization validated per ISO 11135. Shelf-life validated per ASTM F1980-16. Power injection flow rates verified at 330 psi.

Technological Characteristics

Materials: X5CrNi18-10 (needle), TPU (tubing), Copolyester (Luer/Y-site), PP (wing hub/shield), POM (clamp), PE (sheath). Energy: Manual. Connectivity: None. Sterilization: EO (SAL 10^-6). Form factor: Right-angle Huber needle with integrated extension set. Pressure resistance: Up to 330 psi. Standards: ISO 80369-7, ISO 8536-4, ISO 23908, ISO 9626, ISO 7864, ANSI/AAMI CN27, ASTM F3212-16.

Indications for Use

Indicated for adult patients requiring access to surgically implanted vascular ports for infusion of fluids and drugs. High-pressure resistant models are indicated for power injection of contrast media for CT imaging when used with compatible ports.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Surecan Safety II (K170897)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 8, 2023

Promisemed Hangzhou Meditech Co., Ltd. % Wei Shan Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building 300 Hennessy Road, Hong Kong, Hong Kong CHN

Re: K230715

Trade/Device Name: Promisemed Safety Huber Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: May 11, 2023 Received: May 12, 2023

Dear Wei Shan Hsu:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Alan St

CAPT Alan Stevens 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) K230715

Device Name Promisemed Safety Huber Needle

#### Indications for Use (Describe)

The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

#### 1 Date Prepared

June 8th, 2023

#### Submitter's Information 2

# Name of Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

# Address:

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou

City, 311121 Zhejiang, China

# Contact Name:

Zearou Yang

# Telephone No.:

[phone]

Fax No.:

[phone]

Email Address:

[e-mail]

#### ന Trade Name, Common Name, Classification

Trade/Product Name: Promisemed Safety Huber Needle Regulation name: Hypodermic Single Lumen Needle Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: PTI

- ldentification of Predicate Device ব
K170897 Surecan Safety II

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#### Description of the Device റ

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle.

The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B and Type C), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

Image /page/4/Figure/5 description: The image shows the code rule for SHU-1919CHY. The last letter "Y" means that it has a Y injection site. The letter "H" means that the tubing is pressure resistant. The other letters represent the type of safety mechanism, needle length, and needle gauge.

Table 1. Model list

| Type | Model | Note | Gauge | Color |
|--------|---------------------------------------|------------------------------------------------------------|-------|--------|
| Type B | SHU-1919B, SHU-1925B, SHU-1938B | NA | | |
| | SHU-1919BH, SHU-1925BH, SHU-1938BH | Pressure resistance up to 330 psi | | |
| | SHU-1919BY, SHU-1925BY, SHU-1938BY | With Y-injection site | 19G | Cream |
| | SHU-1919BHY, SHU-1925BHY, SHU-1938BHY | Pressure resistance up to 330 psi<br>with Y-injection site | | |
| | SHU-2019B, SHU-2025B, SHU-2038B | NA | | |
| | SHU-2019BH, SHU-2025BH, SHU-2038BH | Pressure resistance up to 330 psi | | |
| | SHU-2019BY, SHU-2025BY, SHU-2038BY | With Y-injection site | 20G | Yellow |
| | SHU-2019BHY, SHU-2025BHY, SHU-2038BHY | Pressure resistance up to 330 psi<br>with Y-injection site | | |
| | SHU-2219B, SHU-2225B, SHU-2238B | NA | | |
| | SHU-2219BH, SHU-2225BH, SHU-2238B | Pressure resistance up to 330 psi | | |
| | SHU-2219BY, SHU-2225BY, SHU-2238BY | With Y-injection site | 22G | Black |
| | SHU-2219BHY, SHU-2225BHY, SHU-2238BHY | Pressure resistance up to 330 psi<br>with Y-injection site | | |
| Type C | SHU-1919C, SHU-1925C, SHU-1938C | NA | 19G | Cream |

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| SHU-1919CH, SHU-1925CH, SHU-1938CH | Pressure resistance up to 330 psi | | |
|---------------------------------------|------------------------------------------------------------|-----|--------|
| SHU-1919CY, SHU-1925CY, SHU-1938CY | With Y-injection site | | |
| SHU-1919CHY, SHU-1925CHY, SHU-1938CHY | Pressure resistance up to 330 psi<br>with Y-injection site | | |
| SHU-2019C, SHU-2025C, SHU-2038C | NA | | |
| SHU-2019CH, SHU-2025CH, SHU-2038CH | Pressure resistance up to 330 psi | | |
| SHU-2019CY, SHU-2025CY, SHU-2038CY | With Y-injection site | 20G | Yellow |
| SHU-2019CHY, SHU-2025CHY, SHU-2038CHY | Pressure resistance up to 330 psi<br>with Y-injection site | | |
| SHU-2219C, SHU-2225C, SHU-2238C | NA | | |
| SHU-2219CH, SHU-2225CH, SHU-2238CH | Pressure resistance up to 330 psi | | |
| SHU-2219CY, SHU-2225CY, SHU-2238CY | With Y-injection site | 22G | Black |
| SHU-2219CHY, SHU-2225CHY, SHU-2238CHY | Pressure resistance up to 330 psi<br>with Y-injection site | | |

Image /page/5/Figure/3 description: The image shows two different types of Huber Needles, labeled as Type B and Type C. Type B has a wing hub and a protective shield, with the Huber Needle extending downwards. Type C also has a wing hub and a protective shield, but the design is more rounded compared to Type B, with the Huber Needle extending downwards as well.

#### 6 Indication

The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

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### 7 Similarities and Differences of the Proposed Devices to the Predicate Devices

The Promisemed Safety Huber Needle is substantially equivalent to the predicate device, Surecan Safety II (K170897) in that these devices have similar intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not raise new questions of safety and effectiveness.

| | Subject Device | Predicate Device<br>(K170897) | |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed Safety<br>Huber Needle | Surecan Safety II | Comments |
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | B. Braun Medical Inc | |
| Device Class | Class II | Class II | Same |
| Product Code | PTI | PTI | Same |
| Regulation number | 880.5570 | 880.5570 | Same |
| Regulation Name | Hypodermic Single<br>Lumen Needle | Hypodermic Single<br>Lumen Needle | Same |
| Intended Use | It is used to access<br>surgically implanted<br>vascular ports and is<br>indicated for use in the<br>administration of fluids<br>and drugs. | Access surgically<br>implanted vascular ports<br>for the infusion of fluids,<br>drugs, and blood<br>sampling | Similar¹<br>The subject<br>device is not<br>intended for blood<br>sampling. |
| Indications for Use | The needle is used to<br>access surgically<br>implanted vascular<br>ports.<br>Safety Huber Needles is<br>a standard non coring<br>intravascular infusion set<br>with a non-coring Huber<br>type right angle needle<br>and a manually activated<br>needle stick prevention<br>safety mechanism which<br>reduces the risk of<br>accidental needlestick<br>injuries by sheathing the<br>needle. This device is for<br>adult use only.<br>In addition, when used | The Surecan Safety II<br>power-injectable safety<br>non-coring needle is a<br>device intended for<br>insertion into the<br>septum of a<br>subcutaneously<br>implanted port for the<br>infusion of fluids and<br>drugs, as well as blood<br>sampling through the<br>port. The Surecan Safety<br>II safety feature is<br>manually activated<br>during needle removal,<br>and is designed to aid in<br>the prevention of<br>accidental needle-sticks. | Similar²<br>The subject<br>device is not<br>intended for blood<br>sampling. |
| | with ports that are<br>indicated for power<br>injection of contrast<br>media into the central<br>venous system, the high<br>pressure resistant model<br>is indicated for high-<br>pressure injection of<br>contrast media for CT<br>imaging. | When used with ports<br>that are indicated for<br>power injection of<br>contrast media into the<br>central venous system,<br>the Surecan Safety II<br>needle is also indicated<br>for power injection of<br>contrast media. | |
| Safety Mechanism<br>Design | Manually activated<br>safety mechanism upon<br>removal of the needle<br>from the implanted<br>vascular port. | Manually activated<br>safety mechanism upon<br>removal of the needle<br>from the implanted<br>vascular port. | Similar 3<br>The subject<br>device has<br>additional type of<br>safety mechanism |
| | Safety mechanism either<br>have a protective shield<br>cover the needle tip<br>(Type B, figure1) or locks<br>needle into place when a<br>firm stop is felt (Type C). | Safety mechanism locks<br>needle into place when a<br>firm stop is felt.<br>A green dot appears on<br>the clear bottom plate<br>when safety mechanism<br>is fully engaged. | (Type B, refer to<br>Table1 and Figure<br>1) |
| Do any sets<br>contain an<br>Injection Site /<br>Luer Access<br>Device? | Yes | Yes | Same |
| Needle bevel<br>design | Non-coring angled<br>needle | Non-coring angled<br>needle | Same |
| Needle Size | 19G,20G,22G | 19G,20G,22G | Same |
| Needle Length | 19mm (0.75 inch)<br>25 mm (1.0 inch)<br>38mm (1.5 inch) | 0.5 inch<br>0.6 inch<br>0.8 inch<br>1.0 inch<br>1.3 inch<br>1.5 inch | Different4<br>Predicate device<br>has wider range. |
| Available for use<br>with contrast<br>media? | Yes for "H" subtype<br>(refer to Table 1) | Yes | Same |
| Does the device<br>have wings? | Yes | Yes | Same |
| Reuse durability | Single use | Single use | Same |
| Ability to<br>withstand power<br>injection pressures | 330 psi ("H" subtype) | 325 psi | Similar5 |
| Flow rates<br>(Pressure<br>injection) | 19, 20 gauge - 5mL/s | 19, 20 gauge - 5mL/s | Same |
| Biocompatibility | 22 gauge - 2 mL/s<br>Complied with ISO10993 | 22 gauge - 2 mL/s<br>Complied with ISO10993 | Similar6 |
| | series standards, and the | series standards, and the | The subject<br>device conducted |
| | following tests are<br>performed | following tests are<br>performed | additional tests,<br>i.e. implantation test and<br>genotoxicity test |
| | - Cytotoxicity: No<br>cytotoxicity | - Cytotoxicity: No<br>cytotoxicity | |
| | - Skin Irritation: No<br>evidence of skin<br>irritation | - Skin Irritation: No<br>evidence of skin<br>irritation | |
| | - Skin Sensitization: No<br>evidence of sensitization | - Skin Sensitization: No<br>evidence of sensitization | |
| | -Acute and Subchronic<br>Systemic Toxicity: No<br>systemic toxicity | -Acute and Subchronic<br>Systemic Toxicity: No<br>systemic toxicity | |
| | -Hemolysis: No evidence<br>of hemolysis | - Hemocompatibility: No<br>evidence of hemolysis | |
| | -Implantation: No<br>abnormal symptoms at<br>the implantation site | -Pyrogen: Non pyrogenic | |
| | - Genotoxicity: No<br>evidence of<br>mutagenticity | | |
| | -Pyrogen: Non pyrogenic | | |
| Configuration and<br>Materials | 1. Huber needle:<br>X5CrNi18-10<br>2. Tubing: TPU<br>3. Luer lock connector:<br>Copolyester<br>4. Y-injection site:<br>Copolyester and<br>silicon<br>5. Protective base: Foam<br>and Copolyester<br>6. Wing hub/Protective<br>shield: PP<br>7.Clamp: POM<br>8.Cap/Needle Sheath: PE | Unknown | Unknown7<br>The material's<br>biosafety is<br>addressed through<br>biocompatibility<br>testing per ISO<br>10993. |
| Performance | Complied with ISO<br>80369-7:2021, ISO8536-<br>4:2019, ISO 23908, ISO<br>9626:2016, ISO<br>7864:2016, ANSI/AAMI<br>CN27:2021, ASTM F3212-<br>16 | Complied with ISO 594-<br>2:1998, ISO 8536-4:2010,<br>ISO 23908:2011, ISO<br>9626:1991, JIS<br>T3221:2011 | Similar8<br>The ISO 594-<br>2:1998 has been<br>replaced by ISO<br>80369-7:2021.<br>The subject<br>device meets the |
| | | | FDA recognized<br>standards. |
| Sterilization<br>method and SAL | EO Sterilization<br>SAL = 10-6 | EO Sterilization<br>SAL = 10-6 | Same |

A detailed comparison to the predicate is provided in Table 1.

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### Discussions of differences in technological characteristics

The subject device has the similar intended use, indications for use, technological characteristics, safety mechanism design when compared to the predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices.

Note 1 and 2: The subject device is not intended for blood sampling, this difference does not affect the substantial equivalence of the device.

Note 3: The subject device has additional type of safety mechanism (Type B, Figure 1) to protect against sharps injury. The sharps protection feature is addressed through testing per ISO23908.

Note 4: The needle length of subject device is within the range of predicate device. The difference needle length does not affect the substantial equivalence of the device.

Note 5: The "H" subtype (refer to Table 1) of subject device withstands power injection pressures of 330 psi, which is higher than predicate device. The flow rate under 330 psi has been verified.

Note 6 and 7: The biocompatibility tests conducted demonstrated the safety of subject device.

Note 8: The subject device meets the requirements of FDA recognized standards.

The differences above do not impact the substantial equivalence of the device.

#### Performance Testing Summary 8

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

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- ISO 8536-4 :2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
- · ISO 23908:2011, Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- · ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
- ANSI/AAMI CN27:2021 General Requirements For Luer Activated Valves (LAVs) Incorporated Into Medical Devices For Intravascular Applications
- ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
- · Power injection flow rate testing (non-standardized test)
- USP<85> Bacterial Endotoxin Test

### Biocompatibility

In accordance with ISO 10993-1 the device is classified as External communicating device, in contact with circulating blood with prongled duration. The biosafety tests that required consideration were validated:

- ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
- · ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute and Subchroic systemic toxicity
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-Genotoxicity Test

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- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- · ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- USP NF 2021 chapter <151> Pyrogen Test
- · USP<788> Particulate matter in injections
- Sterility, Shipping, and Shelf-Life
- · ISO 11135:2014, Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- · Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP39 <71>
- Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- の Conclusion

Based on the information provided within this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.