Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

K170686 · Brightway Holdings Sdn. Bhd. · LZA · Jul 14, 2017 · General Hospital

Device Facts

• Record ID: K170686
• Device Name: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
• Applicant: Brightway Holdings Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; purple color; textured fingers. Provides single-use barrier protection for examiner and patient. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is physical barrier protection; prevents cross-contamination. Does not provide protection against all chemotherapy agents; specifically contraindicated for use with Carmustine and ThioTEPA due to low breakthrough times.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM D6319-10 (physical properties, dimensions, tensile strength, elongation, freedom from holes, residual powder) and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile compound. Form factor: Disposable, powder-free, purple, textured fingers. Standards: ASTM D6319-10 (physical properties), ASTM D6978-05 (chemotherapy permeation), ISO 10993 (biocompatibility). Non-sterile. Standalone device.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978-05.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim (K992162)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 14, 2017

Brightway Holdings Sdn. Bhd. % Dr. Wava Truscott Consultant Truscott Medsci Associates, LLC 180 Burkemeade Ct Roswell. Georgia 30075

Re: K170686

Trade/Device Name: Nitrile Examination Gloves, Powder Free (Purple) Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: June 25, 2017 Received: June 26, 2017

Dear Dr. Truscott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tara A. Ryan -S

for

Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known)

K170686

### Device Name

#### BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUG5

#### Indications for Use (Describe)

### BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows :

| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---------------------------------------------------|-------------------------------------|
| · Blenoxane (15mg/ml),(15,000 ppm) | >240 Minutes |
| · Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| · Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 Minutes |
| · Cisplatin(1.0mg/ml), (1.000 ppm) | >240 Minutes |
| · Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| · Cytarabine(100mg/ml), (100,000 ppm) | >240 Minutes |
| · Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| · Daunorubicin(5mg/ml), (5,000 ppm) | >240 Minutes |
| · Docetaxel(10mg/ml), (10,000 ppm) | >240 Minutes |
| · Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| · Ellence (2mg/ml), (2,000 ppm) | >240 Minutes |
| · Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| · Fludarabine (25mg/ml), (25,000 ppm) | >240 Minutes |
| · Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| · Gemcitabine (38mg/ml), (38,000 ppm) | >240 Minutes |
| · Idarubicin(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| · Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| · Irinotecan(20mg/ml), (20,000 ppm) | >240 Minutes |
| · Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| · Melphalan(5mg/ml), (5,000 ppm) | >240 Minutes |
| · Methotrexate(25mg/ml),(25,000 ppm) | >240 Minutes |
| · Mitomycin C(0.5 mg/ml), (500 ppm) | >240 Minutes |
| · Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| · Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| · Paraplatin (10mg/ml),(10,000 ppm) | >240 Minutes |
| · Rituximab(10mg/ml),(10,000 ppm) | >240 Minutes |
| · Thiotepa (10mg/ml),(10,000 ppm) | 15.9 Minutes |
| · Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |

Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively

#### WARNING: Do Not Use With : Carmustine, ThioTEPA

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)

FORM FDA 3881 (8/14)

Page 1 of 2

PSC Publishing Services [phone] EF

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#### K170686 510(K) SUMMARY

13

## BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS

- 1. Submitter :

| Company Name : | BRIGHTWAY HOLDINGS SDN. BHD. |
|------------------|--------------------------------------------|
| Street Address : | Lot 1559, Jalan Istimewa, |
| | Batu Belah, 42100 Klang |
| | Selangor Darul Ehsan. |
| Country : | Malaysia |
| Phone No. : | 603-3343 1007 & 603-3343 1094. |
| Fax No. : | 603-3341 4800 |
| E-mail Address : | [e-mail] |
| Contact Person : | Mr. G. Baskaran (Group Managing Director) |
| | [e-mail] |
| | Mr. Felix Darrel (Group Marketing Manager) |
| | [e-mail] |

2. Preparation Date : July 13, 2017

3. Name of the Device :

Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE[PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS

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Device Classification Name: Polymer Patient Examination Glove (21 CFR 88-6250)

Device common or usual name: Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

FDA Device Class : Class 1

Product Code : LZC, LZA

- 4. ldentification of the Device :
This Class 1 medical device; product code LZA, LZC with the Trade Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (Purple) TESTED FOR USE WITH CHEMOTHERAPY DRUGS, was tested for Chemotherapy drug penetration resistance per ASTM D6978-05 and meets all the requirements of ASTM D6319-10 and FDA 21 CFR 880.6250.

#### Predicate device:

Legally marked device to which substantial equivalence is claimed:

- 1) K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim
- 5. Device Description :

The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Purple color, powder free and non-sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05.

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#### 6. Intended use of the Device / Indication of Use

ੇ ਮੁੱਤਰ

BRIGHTWAY BRAND EXAMINATION GLOVES, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

This device has been tested with chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration

| | Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---|-------------------------------------------------|-------------------------------------|
| • | Blenoxane (15mg/ml), (15,000 ppm) | >240 Minutes |
| • | Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| • | Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 Minutes |
| • | Cisplatin(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • | Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • | Cytarabine(100mg/ml), (100,000 ppm) | >240 Minutes |
| • | Dacarbazine (DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| • | Daunorubicin(5mg/ml), (5,000 ppm) | >240 Minutes |
| • | Docetaxel(10mg/ml), (10,000 ppm) | >240 Minutes |
| • | Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| • | Ellence (2mg/ml), (2,000 ppm) | >240 Minutes |
| • | Etoposide/Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| • | Fludarabine (25mg/ml), (25,000 ppm) | >240 Minutes |
| • | Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| • | Gemcitabine (38mg/ml), (38,000 ppm) | >240 Minutes |
| • | Idarubicin (1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • | Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| • | Irinotecan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • | Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • | Melphalan(5mg/ml), (5,000 ppm) | >240 Minutes |
| • | Methotrexate(25mg/ml), (25,000 ppm) | >240 Minutes |
| • | Mitomycin C(0.5 mg/ml), (500 ppm) | >240 Minutes |
| • | Mitoxantrone(2mg/ml), (2,000 ppm) | >240 Minutes |
| • | Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| • | Paraplatin (10mg/ml), (10,000 ppm) | >240 Minutes |
| • | Rituximab(10mg/ml), (10,000 ppm) | >240 Minutes |
| • | Thiotepa (10mg/ml), (10,000 ppm) | 15.9 Minutes |
| • | Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| • | Vincristine Sulfate(1.0mg/ml), (1,000 ppm) | >240 Minutes |

Please Note: Carmustine and ThioTEPA have extremely low permeation times with breakthrough detected in less than 30 minutes: Carmustine (3.3mg/mL): 3.6 minutes; ThioTEPA (10mg/mL): 15.9 minutes WARNING: Not for Use with: Carmustine, ThioTEPA

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## 7. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data

a.) Testing was performed per ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application, utilizing the currently re-approved versions of the test methods there-in referenced:

- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— ● Tension
- ASTM D573 Test Method for Rubber—Deterioration in an Air Oven
- ASTM D3578 Specification for Rubber Examination Gloves
- ASTM D3767 Practice for Rubber—Measurement of Dimensions
- o ASTM D5151 Test Method for Detection of Holes in Medical Gloves
- ASTM D6124 Test Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes

Test results show that under the conditions of the testing, there is no difference in physical attributes between the proposed device and the predicate device.

b.) Both the proposed device and the predicate were tested for use with chemotherapy drugs per:

- o ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
c.) Biocompatibility testing was performed utilizing:

- . ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for Irritation and Sensitization. Both dermal irritation and sensitization (Magnusson & Kingman) were performed.
- . ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for Systemic toxicity were conducted as had been performed on the predicate device.

Both the proposed device and the predicate device demonstrated that they were nonirritating and non-sensitizing, and that they did not demonstrate systemic toxicity under conditions of the studies performed.

All testing performed demonstrated that under the conditions of the test or study conducted, that the proposed medical device and the predicate device performed the same or similarly.

## 8. A summary, side by side Comparison Table is presented:

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# 510(k) Summary Table

# Comparison of Proposed Device to Predicate Device (pg. 1 of 2)

| Device<br>Characteristics | Test<br>Standard | Proposed Device | Predicate Device<br>K992162 | Comparison<br>Analysis |
|-------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Trade Name | N/A | Brightway Brand Nitrile<br>Examination Gloves, Powder<br>Free, [Purple] Tested for Use<br>with Chemotherapy Drugs | Safeskin Purple Powder-Free<br>Nitrile Examination Gloves Tested<br>for use with Chemotherapy Drugs | Similar |
| 510(k)<br>Reference | N/A | | K992162 | N/A |
| Common Name | N/A | Patient Examination Glove | Patient Examination Glove | Same |
| Product Code | N/A | LZA, LZC | LZA, LZC | Same |
| Intended use | N/A | A powder-free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiners hand or finger<br>to prevent contamination<br>between patient and examiner.<br>Additionally, the gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM D6978-<br>05 Standard Practice for<br>Assessment of Medical Glove to<br>Permeation by chemotherapy<br>Drugs. | A powder-free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiners hand or finger<br>to prevent contamination<br>between patient and examiner.<br>Additionally, the gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM D6978-<br>05 Standard Practice for<br>Assessment of Medical Glove to<br>Permeation by chemotherapy<br>Drugs. | Same |
| Labeling | N/A | There are no special labeling<br>claims. Does not claim<br>hypoallergenic on label | There are no special labeling<br>claims. Does not claim<br>hypoallergenic on label | Same |
| Regulation<br>Number | N/A | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | N/A | Nitrile | Nitrile | Same |
| Color | N/A | Purple | Purple | Same |
| Textures fingers | N/A | Yes | Yes | Same |
| Design<br>Configurations | ASTM<br>D6319-10 | Extra-Small<br>Small<br>Medium<br>Large<br>Extra-Large | Extra-Small<br>Small<br>Medium<br>Large<br>Extra-Large | Same |
| Dimensions<br>Length | ASTM<br>D6319-10 | All sizes comply with length<br>dimensions | All sizes comply with length<br>dimensions | Same |
| Dimensions<br>Width | ASTM<br>D6319-10 | All sizes comply with width<br>dimensions | All sizes comply with width<br>dimensions | Same |
| Dimensions<br>Thickness | ASTM<br>D6319-10 | All sizes comply with thickness<br>dimensions | All sizes comply with thickness<br>dimensions | Same |
| Device<br>Characteristics | Test<br>Standard | Proposed Device | Predicate Device<br>K992162 | Comparison<br>Analysis |
| Physical<br>Properties -<br>Tensile Strength | ASTM<br>D6319-10 | Complies with ASTM<br>D6319-10 both before and<br>after accelerated aging | Complies with ASTM<br>D6319-10 both before and<br>after accelerated aging | Same |
| Physical<br>Properties -<br>Elongation | ASTM<br>D6319-10 | Complies with ASTM<br>D6319-10 both before and<br>after accelerated aging | Complies with ASTM<br>D6319-10 both before and<br>after accelerated aging | Same |
| Freedom from<br>Holes | ASTM<br>D6319-10<br>by D5151-<br>06 | Pass | Pass | Same |
| Powder Free<br>Designation | ASTM<br>D6319-10<br>by<br>D6124-06 | Less than 2.0 mg per glove;<br>Pass | Less than 2.0 mg per glove;<br>Pass | Same |
| Biocompatibility | ISO 10993-<br>10:2010<br>Reapproved<br>2014 | Under conditions of the test,<br>Not a skin irritant | Under conditions of the test<br>Not a skin irritant | Same |
| | ISO 10993-<br>10:2010<br>Reapproved<br>2014 | Under conditions of the test,<br>Not a skin sensitizer | Under conditions of the test,<br>Not a skin sensitizer | Same |
| | ISO 10993-<br>11:2006<br>Reapproved<br>2010 | Under conditions of the test<br>Does not cause<br>systemic toxicity | Under conditions of the test<br>Does not cause<br>systemic toxicity | Same |
| Prescription vs.<br>ОТС | N/A | ОТС | ОТС | Same |
| Sterile vs.<br>Non-sterile | N/A | Non-Sterile | Non-Sterile | Same |
| Single Use | N/A | Yes | Yes | Same |
| Tested for use<br>with<br>Chemotherapy<br>Drugs | ASTM<br>D6978-05 | Please note: Carmustine and<br>ThioTEPA have extremely low<br>breakthrough times of less<br>than 30 minutes | Please note: Carmustine and<br>ThioTEPA have extremely low<br>breakthrough times of less<br>than 30 minutes | Same |
| Warning | N/A | WARNING: Not for Use with:<br>Carmustine, ThioTEPA | WARNING: Not for Use with:<br>Carmustine, ThioTEPA | Same |

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## Part 10. Executive Summary

# Comparison of Proposed Device to Predicate Device (pg. 2 of 2)

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## 9.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the subject device BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is substantially equivalent to the predicate device K992162 - Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim.

The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR and meets FDA recognized, physical properties requirements, pinhole requirements, powder free requirements, resistance to permeation by chemotherapy drugs testing, biocompatibility studies and labeling requirements presented in this document.

There are no safety or efficacy issues or new claims different from the "substantially equivalent" predicate.

Based on the complete list of non-clinical tests, biological safety studies, labeling, intended use, materials, and processes of manufacture, the subject device herein proposed is as safe, as effective, and performs as well as the legally marketed predicate device.