K Number

Device Name

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180

Manufacturer

ST JUDE MEDICAL, CRMD

Date Cleared

2010-12-21

(160 days)

Product Code

DTA

Regulation Number

870.3720

Intended Use

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads. The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads. The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads. Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

Device Description

The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting. The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable. Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161. Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K022360, K093858

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes patient cables and adapters for connecting leads to a PSA system. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No.
The device is an accessory (patient cable) for a system that assesses pacing and sensing performance of lead systems, not for providing therapy itself.

Diagnostic

Yes

The device's intended use is to "assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting," which describes a diagnostic function.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "patient cable" and "adapter," which are physical hardware components used to connect leads to a medical device. The summary also details hardware-related verification and validation activities like flexibility verification, material and biocompatibility verification, and sterilization process validation.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to connect a device (Merlin PSA) to implantable pacing leads to assess their performance in vivo (within the patient's body). This is a diagnostic procedure performed on the patient, not on a sample taken from the patient.
Device Description: The description reinforces the connection to implanted leads and the assessment of lead system performance.
Lack of IVD Characteristics: The text does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.

Therefore, the Merlin PSA Patient Cable and its adapters are accessories used in a diagnostic procedure performed directly on the patient, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads.

The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads.

The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads.

Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

Product codes (comma separated list FDA assigned to the subject device)

DTA

Device Description

Merlin PSA EX3150 Patient Cable:

The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable.

Merlin PSA EX3170 and EX3180 Patient Cable Adapters:

Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables

Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161.

Merlin PSA "M" Adapter EX3180 connects to the Medtronic™ Model 2292 patient cable.

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

Not Found

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)

Verification and validation activities necessary to ensure that the SJM Merlin PSA Patient Cable's and adapter's product and system requirements were fulfilled have been successfully performed.

Product verification is documented in the following reports:

Patient Cable EX3150 Design Verification Test Report
Patient Cable EX3150 Flexibility Verification Test Report
Patient Cable EX3150 Material and Biocompatibility Verification Report
Patient Cable EX3150 Shipping and Packaging Test Report
Patient Cable EX3150 Shelf life Aging Verification Report
Patient Cable EX3150 Cleaning and Sterilization efficiency verification for re-usable cables report
Patient Cable EX3150 Aging for re-usable cables Verification Report
Patient Cable EX3150 Sterilization Process Validation Report
Adapter EX3170 Verification Test Report
Adapter EX3180 Verification Test Report
Adapter EX3170/80 Shipping and Packaging Test Report
PSA System Verification Report

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.

K022360, K093858

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

Regulation Number and Section

§ 870.3720 Pacemaker electrode function tester.

(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).

Summary

K101982

PREMARKET NOTIFICATION [510(k)] SUMMARY

Date Prepared:	July 13th, 2010
Submitter:	St. Jude Medical, CRMD	DEC 21 2010
Address:	701 E. Evelyn Avenue
Sunnyvale, CA 94086
Phone:	408-522-6775
Fax:	408-522-6440
Contact Person:	Gina Correa
Trade Name/Proprietary Name:	Merlin™ PSA Patient Cable EX 3150
Merlin™ PSA Cable Adapter EX3170
Merlin™ PSA “M” Adapter EX3180
Common Name:	PSA Patient Cable and Adapters
Model Numbers: EX 3150, EX3170, EX3180 (Accessories)
Classification:	Class II, 21CFR870.3720
Legally marketed device to which your firm is claiming equivalence:	Biotronik Patient Cable PK 67-L and the PA-4 Adapter (K022360 cleared on January 27, 2003) and St. Jude Medical PSA Cable Adapter Model Number 4053A (K093858 cleared on April 2, 2010)

INDICATIONS FOR USE/INTENDED USE

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads.

Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

DEVICE DESCRIPTION:

Merlin PSA EX3150 Patient Cable:

Please find below a schematic of the Merlin PSA Patient cable EX3150:

Image /page/1/Figure/6 description: The image shows a coiled cable with multiple labeled components. The cable has a connector at one end, labeled as '1', and a grip labeled as '2'. Further along the cable, there are labels '3', '4', '5', '6', and '7'. At the other end of the cable, there are multiple connectors labeled '8a', '8b', '8c', '8d', '8e', '8f', '9', and '10'.

Figure 1 : Merlin PSA Patient Cable, Model EX3150

1. ODU connector, PSA-unit side
1. Connector bend relief, PSA-unit side

1. Ferrite
  Cable - trunk part 4.

Patient clip
Branching block
Anti-twist function (x3)

1. a) Lead wire LV+ (Left Ventricle)
  b) Lead wire LV - (Left Ventricle)

c) Lead wire RV+ (Right Ventricle)

d) Lead wire RV (Right Ventricle)
e) Lead wire A+ (Atrium)
f) Lead wire A- (Atrium)
1. Alligator clip strain relief (x6)

Alligator clip, lead part (x6)

The PSA Patient cable, Model EX3150 is the interface between the implanted leads and the PSA unit. The patient cable is connected to the front panel of the Merlin PSA EX3100. Please find below a schematic of the Merlin PSA unit.

Image /page/2/Picture/15 description: The image shows a piece of equipment with several labeled components. The top surface of the equipment, labeled as '1', has various indicators and ports. On the left side, there is a component labeled '2', and further to the right, there are three circular ports labeled '3', '4', and '5'. Cables are connected to the equipment from the top, labeled as '6'.

Figure 2: Merlin PSA, Pacemaker System Analyzer EX3100-Connector for patient cable or patient-cable adapter is identified as #3

The PSA Patient cable EX3150 is used during the implantation procedure to measure if the lead picks up signals from the heart accurately. It is connected to the lead by clamping the alligator clip to the connector pin of the lead.

Technological Characteristics of the Merlin PSA Patient cable EX 3150 Compared to the Predicate Device:

The Merlin PSA patient cable EX 3150 has similar intended uses, functionality and method of operation as the following predicate device.

Biotronik Patient Cable PK 67-L and the PA-4 Adapter (K022360 cleared on January 27, 2003)

A brief summary of the SJM Merlin PSA cable EX3150 compared to the Predicate cable is provided below:

| | Merlin PSA
Patient Cable
Model EX3150 | Biotronik Patient
Cable Model
PK67-L + PA 4
adapter |
|----------------------------------------------------|---------------------------------------------|--------------------------------------------------------------|
| Channels | A, RV, LV | A, V |
| Cable trunk
material | Silicone | Silicone |
| Length | 4.07 m | 2.64 m + 0.32 m
PA 4 adapter |
| Re-sterilization
method | Steam | Steam |
| Clip design | Non-dented
Alligator clips | Alligator clips |
| Compatible lead
connectors | IS-1, SJ-4 | IS-1 |
| Touch proof lead
connectors/ alligator
clips | Yes | No |
| Touch proof PSA
connectors | Yes | Yes |
| Lead connection
isolation | Built-in clip
isolation | Isolation caps |
| Channel labeling | Text and color | Text and color |
| Polarity labeling | Text and color | Text and color |
| Anti-twist clip on
distal cabling | Yes | Yes |
| Patient clip | Yes | No |
| Serial number | Yes | No |

Merlin PSA EX3170 and EX3180 Patient Cable Adapters:

Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables

Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161.

Please find below a schematic of the Merlin PSA cable adapter EX3170:

Image /page/4/Picture/1 description: The image shows a device with several labeled components. At the left end, there's a cylindrical part labeled '1', followed by a section marked '2'. Moving right, there's a larger, bulbous component labeled '3', connected to a tube marked '4'. The device ends with a rectangular box labeled '5', which has a small feature labeled '6' on its side. The device appears to be lying on a textured surface.

Figure 3 : Merlin PSA Cable Adapter EX3170

1. ODU connector, connects to the Merlin PSA EX3100
1. Connector bend relief
1. Ferrite
1. Cable
1. Branching block
1. Hypertronics connector (x3)

Merlin PSA "M" Adapter EX3180 connects to the Medtronic™ Model 2292 patient cable.

Image /page/4/Picture/10 description: The image shows a long, thin object with several distinct parts. The object has a cylindrical shape with varying diameters along its length. There are numbers labeling different sections of the object, from 1 to 6, and 11, indicating specific components or features. The object appears to be a tool or instrument, possibly used for scientific or technical purposes.

Please find below a schematic of the Merlin PSA cable adapter EX3180:

Figure 4 : Merlin PSA "M" Adapter EX3180

1. ODU connector, connects to the Merlin PSA EX3100
1. Connector bend relief
1. Ferrite
1. Cable

1. Connector block

Hypertronics connector

Technological Characteristics of the Merlin PSA patient cable adapters EX 3170 and EX 3180 compared to the Predicate Device:

The Merlin PSA patient cable adapters EX 3170 and EX3180 have similar intended uses, functionality and method of operation as the following predicate device.

St. Jude Medical Model 4053A Patient Cable adapter (K093858 cleared on April 2010).

A brief summary of the SJM Merlin PSA cable adapters EX 3170 and EX3180 compared to the Predicate cable adapter is provided below:

	4053A	EX3170	EX3180
PSA compatibility	SJM: 3150 & EX3100
2-channels	SJM: EX3100
3-channels	SJM: EX3100
2-channels
PSA Connector	Touch Proof Plastic
Connector with snap
on function and
mechanical keying	Touch Proof Plastic
Connector with snap
on function and
mechanical keying	Touch Proof Plastic
Connector with snap
on function and
mechanical keying
PSA Connector Bend
Relief	Pre-molded
Polyurethane
Elastomer	Molded Santoprene	Molded Santoprene
Raw Cable	PTFE insulated wires,
wires twisted in pairs
inside a braided
shield, Outer Jacket in
Santoprene	PTFE insulated wires,
wires twisted in pairs
inside a braided
shield, Outer Jacket in
Santoprene	PTFE insulated wires,
wires twisted in pairs
inside a braided
shield, Outer Jacket in
Santoprene
Ferrite	Ferrite over molded
with Santoprene	Ferrite over molded
with Santoprene	Ferrite over molded
with Santoprene
Connector Block
Bend Relief	Molded Santoprene	Molded Santoprene	Molded Santoprene
Connector Block	Connectors over
molded with
Santoprene with clear
marking of channels
and branding	Connectors over
molded with
Santoprene with clear
marking of channels
and branding	Connectors over
molded with
Santoprene with clear
marking of branding
Patient Cable
Connector	Hypertronics	Hypertronics	Hypertronics
Patient Cable type to
be connected	2 pairs of 4051/4051A
or 4161 sterile Patient
Cables	3 pairs of 4051/4051A
or 4161 sterile Patient
Cables	1 sterile 2292 Patient
Cable

Summary of Studies:

Verification and validation activities necessary to ensure that the SJM Merlin PSA Patient Cable's and adapter's product and system requirements were fulfilled have been successfully performed.

| Appendix 5.1 | Patient Cable EX3150 Design Verification
Test Report |
|---------------|------------------------------------------------------------------------------------------------------------|
| Appendix 5.2 | Patient Cable EX3150 Flexibility Verification
Test Report |
| Appendix 5.3 | Patient Cable EX3150 Material and
Biocompatibility Verification Report |
| Appendix 5.4 | Patient Cable EX3150 Shipping and
Packaging Test Report |
| Appendix 5.5 | Patient Cable EX3150 Shelf life Aging
Verification Report |
| Appendix 5.6 | Patient Cable EX3150 Cleaning and
Sterilization efficiency verification for re-
usable cables report |
| Appendix 5.7 | Patient Cable EX3150 Aging for re-usable
cables Verification Report |
| Appendix 5.8 | Patient Cable EX3150 Sterilization Process
Validation Report |
| Appendix 5.9 | Adapter EX3170 Verification Test Report |
| Appendix 5.10 | Adapter EX3180 Verification Test Report |
| Appendix 5.11 | Adapter EX3170/80 Shipping and Packaging
Test Report |
| Appendix 5.12 | PSA System Verification Report |

Product verification is documented in the following reports:

Biocompatibility:

Material and Biocompatibility testing was performed on the Merlin PSA Patient Cable EX3150. All units tested passed the acceptance criteria. The report is provided in Appendix 5.3.

By design, the Merlin PSA Cable Adapter EX 3170 and the Merlin PSA "M" Adapter EX 3180 does not make blood tissue contact; hence no biocompatibility testing is required.

Packaging and Shelf life:

The PSA Patient cable EX3150 packaging configuration consists of a single Tyvek Sterile pouch providing the sterile barrier, which is packaged in a single Product box to protect the content. These are in turn packaged into a 20 Multipack box.

The tests that were conducted to demonstrate integrity and robustness of packaging and shelf life aging conditions for the Merlin PSA Cable EX3150 are reported in the Packaging/Shipping Test Report, see Appendix 5.4. and the Shelf life verification report, see Appendix 5.5.

Please refer to the figures below describing the various packaging configurations.

Image /page/7/Picture/3 description: The image shows a packaged set of wires. The wires are coiled inside of a clear plastic bag. A label is attached to the bag with a barcode and some text.

Figure 5: EX3150 Cable Assembly, including Tyvek® Pouch with Label

Image /page/7/Picture/5 description: The image shows a rectangular object, possibly a package or container, lying on a textured surface. The object appears to be made of a light-colored material, and it has some markings or labels on its surface. The surface beneath the object has a grid-like pattern, suggesting it could be a tiled or textured floor. The object is slightly damaged.

Figure 6: EX3150 Single Product Box with label, insert and Cable assembly and labeled Pouch placed inside.

Image /page/7/Picture/7 description: The image shows an aerial view of a building complex. The buildings are rectangular and appear to be made of concrete. There are several roads and parking lots surrounding the buildings. The image is taken from a high angle, giving a wide view of the complex and the surrounding area.

Figure 7: Single Product Box with Label

Image /page/7/Picture/9 description: The image shows an open cardboard box. The box is empty and has flaps that are open. The box is made of brown cardboard and has a rectangular shape. The box is sitting on a flat surface.

Figure 8: 20 Multipack Box

The Merlin PSA Cable Adapter EX3170 and Merlin PSA "M" Adapter EX3180 are packaged in a resealable bag. These are in turn packaged into a 50 Multipack box.

The test samples were packaged for standard shipment in accordance with our approved packing procedures and subjected to the ISTA 3A shipping test program for testing.

The tests that were conducted to demonstrate package integrity and robustness of shipping conditions for the Merlin PSA Cable Adapter EX3170 and Merlin PSA "M" Adapter EX3180. These tests were carried out and are reported in the Adapter EX3170/80 Shipping Test Report, see Appendix 5.11.

Merlin PSA Cable Adapter EX3170 and Merlin PSA "M" Adapter EX3180 are not supplied sterile and are not designed with any shelf life limiting components. Therefore shelf-life testing was not required. This is consistent with other market cleared SJM accessories.

Please refer to the figures below describing the various packaging configurations.

Image /page/8/Picture/6 description: The image shows a medical device and a package. The medical device is a needle with a white handle. The package has a label with text on it, but the text is not legible.

Figure 9: Merlin PSA Cable Adapter EX3170 is packaged in a resealable bag with packaging label

ನ್ನ

Image /page/9/Picture/1 description: The image shows a small metal adapter and a label. The label appears to say "MERLIN PFA 'M' ADAPTER". The adapter is silver and has a cylindrical shape with a smaller diameter in the middle.

Figure 10: Merlin PSA "M" Adapter EX3180 is packaged in a resealable bag with packaging label

Image /page/9/Picture/3 description: The image shows a close-up of a textured surface, possibly a wall or a piece of fabric. The texture appears rough and uneven, with a mix of light and dark areas. The lighting in the image is somewhat diffused, creating soft shadows and highlights that accentuate the texture. The overall impression is one of age and wear, suggesting that the surface has been exposed to the elements or has undergone some form of degradation.

Figure 11: 50 Multipack Box

Sterilization:

The sterilization validation for the PSA Patient cable EX3150 was performed and reported in the Sterilization Process Validation report. See Appendix 5.8. The PSA Patient Cable is sterilized using 100% Ethylene Oxide prior to distribution. The sterility assurance level for the PSA Patient cable is verified to be 10-6.

Re-sterilization:

The Merlin PSA Patient cable EX3150 is intended for re-use in clinics. Verified methods for cleaning and re-sterilizing the PSA Patient Cable can be found in the Merlin PSA EX3100 Help Manual. See Appendix 3.2. The efficiency of the specified reprocessing methods has been documented in the Cleaning and Sterilization efficiency report. See Appendix 5.6. The integrity

of product performance has been documented in the Aging for Re-usable cables report. See Appendix 5.7.

Merlin PSA Cable Adapter EX3170 and Merlin PSA "M" Adapter EX3180 are not supplied sterile and are not intended to be used sterile. The materials used to manufacture the Merlin PSA EX3100 system are generic and do not specify a shelf life criteria. Therefore no shelf life is specified. This is consistent with other non-sterile SJM cable accessories.

Conclusion:

St. Jude Medical considers the SJM Merlin PSA Patient Cable EX3150 and the Merlin PSA patient cable adapters EX3170 and EX3180 to be substantially equivalent to the legally marketed predicate and referenced devices.

The results of the tests and complicable standards (reference Section 6) provide reasonable assurance that the SJM Merlin PSA Patient Cable and Adapters (EX 3150, EX3170 and EX3180) have been designed and tested to assure conformance to the requirements for its indications for use.

Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The overall design is simple and conveys a sense of authority and professionalism.

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

St. Jude Medical, CRMD c/o Ms. Gina Correa 701 E. Evelyn Avenue Sunnyvale, CA 94086

DEC 2 1 2010

Re: K101982

Trade/Device Name: MerlinTM PSA Patient Cable - EX3150 Merlin™ PSA Patient Cable Adapter - EX3170 Merlin™ PSA "M" Adapter-- EX3180 Regulation Number: 21 CFR 870.3720 Regulation Name: Pacemaker Electrode Function Tester Regulatory Class: Class II (two) Product Code: DTA Dated: December 9, 2010 Received: December 10, 2010

Dear Ms. Correa:

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.

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.

Page 2 - Ms. Gina Correa

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 (reporting of medical device-related 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 100-050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): 《1019 82

Device Name: Merlin™ PSA Patient Cable - EX3150 Merlin™ PSA Patient Cable Adapter - EX3170 Merlin™ PSA "M" Adapter EX3180

Indications for Use:

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads.

Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

DEC 2 1 2010

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.C

diovascular De

510(k) Number K011782