(268 days)
Not Found
No
The document describes a simple electrical connector and does not mention any AI/ML terms or functionalities.
No
Explanation: This device is described as a "rotatable connector" intended to "connect a cardiovascular stimulating instrument to a cardiac pacing lead." It facilitates the connection for a temporary cardiac pacing system but does not itself provide therapy. The "cardiovascular stimulating instrument" or the "cardiac pacing lead" would be the therapeutic components, not the connector.
No
The device is described as a "rotatable connector" that "connects a cardiovascular stimulating instrument to a cardiac pacing lead." Its function is to facilitate the connection between two other medical devices, not to diagnose a condition.
No
The device description clearly states it is a pair of single use, disposable surgical cables with two adaptors, which are physical hardware components. The performance studies also focus on physical characteristics like biocompatibility, sterilization, and mechanical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for connecting a cardiovascular stimulating instrument to a cardiac pacing lead as part of a temporary cardiac pacing system. This is a direct connection to the body for therapeutic purposes (pacing the heart), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its function as a surgical cable for connecting instruments to a pacing lead.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, usability, and electrical/mechanical safety, which are relevant to a device used in direct contact with the body, not for in vitro testing.
In summary, the device's function is to facilitate the delivery of electrical signals for cardiac pacing, which is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the living body) diagnostic test.
N/A
Intended Use / Indications for Use
The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians in a clinical environment.
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)
5944RL Rotatable Connector was evaluated for biocompatibility, sterilization, usability as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standard, The 5944RL Rotatable Connector complies with voluntary standards:
-
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
-
- IEC 60601-1-2 Edition 4.1 2020-09 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: റ്റ് Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: 4. Tests for skin sensitization
-
- ISO 11737-1:2018/A1:2021 Sterilization of health care products -Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ISO 11737-2 Third edition 2019-12 Sterilization of health care products-6. Microbiological methods-Part2:Tests of sterility performed in the definition, validation and maintenance of a s sterilization process
- ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible 7. Barrier Materials
- ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting 8. Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
-
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
-
- IEC 60601-2-31: 2020: Medical electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2025
Shenzhen Launch Electrical Co. Ltd Christina Zheng Assistant of General Manager Bldg F, Zhonggangxing Industrial Estate Zhangge Community Guanian Street, Longhua New District Shenzhen. 518110 China
Re: K241199
Trade/Device Name: Rotatable Connector (5944RL) Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: December 23, 2024 Received: December 23, 2024
Dear Christina Zheng:
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"
1
Page
2
(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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature includes the name "Sara M. Royce -S" on the left side and "Digitally signed by Sara M. Royce -S" on the right side. The date and time of the signature are also included, with the date being "2025.01.23" and the time being "15:22:58 -05'00'".
Sara Royce Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Rotatable Connector (5944RL)
Indications for Use (Describe)
The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.
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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4
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510(k) Summary
K241199
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date Prepared: | Jan 21st, 2025 |
|---|---|
| Manufacturer: | Shenzhen Launch Electrical Co. Ltd |
| Building F, Zhonggangxing Industrial Estate | |
| Zhangge Community, Guanian Street, | |
| Longhua New District, Shenzhen 518110, | |
| China | |
| Contact Person: | Christina Zheng |
Assistant of General Manager Shenzhen Launch Electrical Co. Ltd Tel: +86-18825224607 email: christina.zheng@lnhmed.com
ldentification of the Device:
| Proprietary/Trade Name: | 5944RL Rotatable Connector |
|---|---|
| Classification Name: | Electrode, Pacemaker, Temporary |
| Regulation Name: | Cardiovascular permanent or temporary pacemaker electrode |
| Regulatory Number: | 21 CFR 870.3680 |
| Product Code: | LDF |
| Device Class: | Class II |
| Review Panel: | Cardiovascular |
Primary Predicate Device:
| Proprietary/Trade Name: | MEDTRONIC 5833SL |
|---|---|
| Classification Name: | Electrode, Pacemaker, Temporary |
| Regulation Name: | Cardiovascular permanent or temporary |
| pacemaker electrode | |
| Regulatory Number: | 21 CFR 870.3680 |
| Product Code: | LDF |
| Device Class: | Class II |
| Review Panel: | Cardiovascular |
5
UNHmed
510(k) Premarket Notification Submission
| Submitter/510(k) Holder: | MEDTRONIC VASCULAR 7000 CENTRAL
AVE. N.E. MINNEAPOLIS, MN 55432 |
|--------------------------|--------------------------------------------------------------------|
| Clearance: | K923407 (cleared Oct 19, 1992) |
Device Description:
The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.
Indications for Use:
The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.
Comparison with Predicate Device:
The 5944RL Rotatable Connector and its predicate device the 5833SL Disposable surgical cables (K923407), have the same intended use, and similar physical characteristics.
| Description | Subject Device | Predicate Device | |
|---|---|---|---|
| 5944RL | |||
| Rotatable Connector | 5833SL | ||
| Disposable surgical | |||
| cables | |||
| 510K number | K241199 | K923407 | |
| Manufacturer | Launch | Medtronic Vascular | |
| Product code, | |||
| Classification | LDF | ||
| 21 CFR 870.3680 | |||
| Class II | LDF | ||
| 21 CFR 870.3680 | |||
| Class II | |||
| Indications for use | The rotatable connector | ||
| is intended for use as | |||
| part of a temporary | |||
| cardiac pacing system. | |||
| It connects a | |||
| cardiovascular | |||
| stimulating instrument | |||
| to a cardiac pacing | |||
| lead. It is intended for | |||
| use by trained clinicians | |||
| in a clinical | |||
| environment. | The Medtronic Model | ||
| 5833SL disposable | |||
| surgical cables are | |||
| intended for use as | |||
| part of a temporary | |||
| cardiac pacing system. | |||
| They connect a single | |||
| chamber or dual | |||
| chamber | |||
| cardiovascular | |||
| stimulating instrument | |||
| to cardiac pacing leads | |||
| or heart wires | |||
| Description | Subject Device | Predicate Device | |
| 5944RL | |||
| Rotatable Connector | 5833SL | ||
| Disposable surgical | |||
| cables | |||
| Intended User | The Model 5944RL | ||
| patient cable is | |||
| intended for use by | |||
| trained clinicians. | It is intended for use by | ||
| trained clinicians. | |||
| Intended Use | |||
| Environment | clinical environment | clinical environment | |
| Duration of use | Limited : ≤24H | Limited : ≤24H | |
| Single use, disposable | Yes | Yes | |
| Provided sterile | Yes | Yes | |
| Sterilization method | EO | Radiation | |
| Sterility Assurance | |||
| Level (SAL) | ≤ 10-6 | ≤ 10-6 | |
| Sterile barrier package | Tyvek Flexible Barrier | Tyvek Flexible Barrier | |
| Product | |||
| picture | Image: [red cable with alligator clips] | Image: [white cable with red and black connectors] | |
| Design | Principles of | ||
| operation | The device is used as | ||
| part of a temporary | |||
| cardiac pacing system | |||
| based on the principle | |||
| of transmitting electrical | |||
| signals between the | |||
| cardiovascular | |||
| stimulating instrument | |||
| and the cardiac pacing | |||
| leads. The device | |||
| allows real-time | |||
| continuous and | |||
| accurate pacing and | |||
| sensing electrical | |||
| connection during lead | |||
| implantation. After the | The Medtronic Model | ||
| 5833SL cable is single | |||
| use, disposable | |||
| surgical cables. The | |||
| cables are designed to | |||
| connect a | |||
| cardiovascular | |||
| stimulating instrument | |||
| to cardiac pacing lead | |||
| system. | |||
| Description | Subject Device | Predicate Device | |
| 5944RL | |||
| Rotatable Connector | 5833SL | ||
| Disposable surgical | |||
| cables | |||
| implantation procedure | |||
| is finished, the device is | |||
| disconnected and | |||
| discarded. | |||
| Function | The Model 5944RL | ||
| rotatable connector is a | |||
| pair of single use, | |||
| disposable surgical | |||
| cables with two | |||
| adaptors. The cables | |||
| are designed to connect | |||
| a cardiovascular | |||
| stimulating instrument | |||
| to a cardiac pacing lead | |||
| system. | The Medtronic Model | ||
| 5833SL cables are | |||
| single use, disposable | |||
| surgical cable. The | |||
| cable is designed to | |||
| connect a | |||
| cardiovascular | |||
| stimulating instrument | |||
| to a cardiac pacing | |||
| lead system. | |||
| Construction | This device consists of | ||
| a pair of connection | |||
| cables, which includes | |||
| a cathode cable (black | |||
| wire) and an anode | |||
| cable (red wire) and a | |||
| pair of un-shrouded pin | |||
| adaptors. | |||
| The anode cable has an | |||
| alligator clip at the distal | |||
| end, and a 2 mm | |||
| shroud pin at the | |||
| proximal end. | |||
| The cathode cable has | |||
| a rotatable lead | |||
| connector at the distal | |||
| end of the cable, and a | |||
| 2 mm shroud pin at the | |||
| proximal end. | |||
| The distal end of the | |||
| respective cables | The proximal end of | ||
| each cable consists of | |||
| a connector with 2 | |||
| recessed pins that | |||
| plugs into a | |||
| cardiovascular | |||
| stimulating instrument. | |||
| The distal end of each | |||
| cable consists of 2 | |||
| alligator clips with | |||
| color-coded boots that | |||
| attach to the connector | |||
| pins of | |||
| cardiac leads. The red | |||
| clip is positive (+). The | |||
| black clip is negative | |||
| (-). | |||
| Plug is Type CF | |||
| connection plug, which | |||
| is connected to Type | |||
| Description | Subject Device | Predicate Device | |
| 5944RL | |||
| Rotatable Connector | 5833SL | ||
| Disposable surgical | |||
| cables | |||
| clip and rotatable | |||
| connector that attach to | |||
| the electrode contacts | |||
| of the cardiac pacing | |||
| lead or a unipolar | |||
| reference. The alligator | |||
| clip with the red wire is | |||
| positive (+). The | |||
| rotatable connector with | |||
| black wire is negative | |||
| (-). |
Plug type is shroud pin
or safety connector
pin, which is
connected to type of pin
receptacle. | | |
| Method of
clamp
introduction | Image: 5944RL Rotatable Connector | Image: 5833SL Disposable surgical cables | |
| | Male to female
connector,
Alligator clips | Male to female
connector,
Alligator clips | |
| Performance | Key performance
-Cable segment: 22
AWG
-Resistance ≤5Ω
-Insulation
resistance >1GΩ
-Dielectric withstanding
voltage: capable of
1500 volts A.C. for one | Key performance
-Cable segment: 22
AWG
-Resistance ≤5Ω
-Insulation
resistance >1MΩ
-Dielectric withstanding
voltage: capable of
1500 volts A.C. for one | |
| Description | Subject Device | Predicate Device | |
| | 5944RL
Rotatable Connector | 5833SL
Disposable surgical
cables | |
| Patient Contact
Materials | Cytotoxicity, Irritation,
Sensitization and meet
ISO 10993-1 and FDA
guidance | Cytotoxicity, Irritation,
Sensitization and meet
ISO 10993-1 and FDA
guidance | |
| Electrical Safety and
Electromagnetic
compatibility | ANSI/AAMI ES60601-1
IEC60601-1-2 | ANSI/AAMI ES60601-1
IEC60601-1-2 | |
| Labeling | Conforms to 21 CFR
Part 801 | Conforms to 21 CFR
Part 801 | |
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510(k) Premarket Notification Submission
7
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510(k) Premarket Notification Submission
8
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510(k) Premarket Notification Submission
9
UNHmed
510(k) Premarket Notification Submission
Technology:
The 5944RL Rotatable Connector employs the same fundamental scientific technology as its predicated device.
Summary of Substantial Equivalence Comparison:
The subject devices have the same Indications for use, Intended User and use environment, same technological characteristics including Principles of operation, functions and performance, biocompatibility and general safety, only the sterilization method, construction design and Insulation resistance of performance different and they do not raise new questions of safety and effectiveness.
Summary of Non-clinical test:
5944RL Rotatable Connector was evaluated for biocompatibility, sterilization, usability as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standard, The 5944RL Rotatable Connector complies with voluntary standards:
-
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
-
- IEC 60601-1-2 Edition 4.1 2020-09 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
10
UNHmed
510(k) Premarket Notification Submission
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: റ്റ് Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: 4. Tests for skin sensitization
-
- ISO 11737-1:2018/A1:2021 Sterilization of health care products -Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ISO 11737-2 Third edition 2019-12 Sterilization of health care products-6. Microbiological methods-Part2:Tests of sterility performed in the definition, validation and maintenance of a s sterilization process
- ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible 7. Barrier Materials
- ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting 8. Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
-
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
-
- IEC 60601-2-31: 2020: Medical electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Summary of Clinical Tests:
The subject of this premarket submission did not require clinical studies to support substantial equivalence.
Conclusion:
Shenzhen Launch Electrical Co. Ltd considers the 5944RL Rotatable Connector to be substantially equivalent to the predicate device.