The MobiCath Transseptal Needle is used to create the primary puncture in the interatrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

Device Description

The MobiCath Transseptal Needles consist of a thin-walled stainless steel cannula bonded to an ergonomic handle and stopcock, and a removable stylet. The cannula is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with an introducer or catheter. The handle is integrated with a pointer to show the orientation of the curve. The two-way stopcock facilitates air aspiration, fluid infusion, blood sampling, and pressure monitoring. The stylet attaches to the proximal end of the needle assembly.

AI/ML Overview

Here's an analysis of the provided text regarding the MobiCath Transseptal Needle, focusing on the acceptance criteria and the study that proves the device meets them.

This document describes a 510(k) submission for a modified medical device, specifically stating "Greatbatch Medical proposes using an alternate stopcock for the MobiCath Trasseptal Needles. The current stopcock has been discontinued by the supplier. A similar stopcock has been tested as a replacement. A few minor design changes are required for the stopcock to interface with the handle components. In addition, a few manufacturing improvements have been proposed." This means the studies are not for a novel device but to demonstrate substantial equivalence of the modified device to a previously cleared predicate device (MobiCath Transseptal Needle K111644).

Therefore, the "acceptance criteria" here are to demonstrate that the changes have not introduced new safety or efficacy issues and that the device performs equivalently to the predicate. The "study" refers to a battery of non-clinical tests.

Acceptance Criteria and Device Performance

The provided document doesn't explicitly list "acceptance criteria" with numerical thresholds in a table format for each test. Instead, it describes a series of tests performed to ensure the modified device (with a new stopcock) maintains the same performance and safety profile as the predicate device. The implied acceptance criterion for each test is that the modified device performs comparably to the predicate or within established engineering specifications for the original device.

Since specific numerical thresholds for acceptance are not provided, the "Reported Device Performance" is generally stated as "risks have been mitigated and that no new safety or efficacy issues were raised," implying successful completion of the tests.

Acceptance Criterion Category	Specific Tests Performed	(Implied) Acceptance Criterion	Reported Device Performance
Design Verification Bench	Visual & Dimensional Inspection	Device visually and dimensionally conform to specifications for the modified design, ensuring proper fit and function with handle components.	Risks mitigated, no new safety/efficacy issues raised.
	Functional Testing (Tensile, Torque, Stopcock gauging)	Device components (stopcock, handle) withstand specified forces and exhibit expected mechanical properties (tensile strength, torque resistance, proper gauging).	Risks mitigated, no new safety/efficacy issues raised.
	Air and liquid leakage	No leakage of air or liquid through the stopcock or its interfaces.	Risks mitigated, no new safety/efficacy issues raised.
	Stopcock separation force	Stopcock remains securely attached to the handle during normal use and within specified force limits.	Risks mitigated, no new safety/efficacy issues raised.
	Stopcock resistance to override	Stopcock function (e.g., stopping flow) cannot be easily overridden unintentionally.	Risks mitigated, no new safety/efficacy issues raised.
	Stopcock ease of assembly	Stopcock can be assembled easily and correctly with the handle.	Risks mitigated, no new safety/efficacy issues raised.
	Stopcock stress cracking	Stopcock material does not exhibit stress cracking under specified conditions.	Risks mitigated, no new safety/efficacy issues raised.
	Stylet to stopcock retention force	Stylet is retained by the stopcock with appropriate force during use.	Risks mitigated, no new safety/efficacy issues raised.
	Stylet insertion through needle	Stylet can be inserted smoothly and correctly through the needle.	Risks mitigated, no new safety/efficacy issues raised.
Biocompatibility Testing	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Rabbit Pyrogenicity, Hemocompatibility (Hemolysis, Partial Thromboplastin Time, Platelet and Leukocyte Counts, Complement Activation C3a and SC5b-9)	Materials are biocompatible, non-toxic, non-irritating, non-sensitizing, non-pyrogenic, and do not cause adverse hematological reactions.	Risks mitigated, no new safety/efficacy issues raised.
Package Distribution	Packaging protects the device during distribution.	Risks mitigated, no new safety/efficacy issues raised.
Shelf Life	Device maintains its safety and performance characteristics for its specified shelf life.	Risks mitigated, no new safety/efficacy issues raised.
Sterilization Rationale	Sterilization method is effective and validated.	Risks mitigated, no new safety/efficacy issues raised.
EtO Residual Testing	Ethylene Oxide (EtO) residuals are within acceptable limits after sterilization.	Risks mitigated, no new safety/efficacy issues raised.

Study Details

Sample sizes used for the test set and data provenance:
- The document does not specify sample sizes for any of the non-clinical tests.
- The data provenance is not explicitly stated in terms of country of origin, but it is clear these are retrospective tests conducted by Greatbatch Medical to support the 510(k) submission for a device modification. They are lab-based tests, not clinical studies involving patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable here. These are non-clinical engineering and biological tests conducted in a laboratory setting, not studies involving human interpretation of medical data (like radiology images). "Ground truth" in this context would refer to established engineering specifications or industry standards, which are not set by human experts in the sense implied by the question.
Adjudication method for the test set:
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or diagnostic studies where multiple readers interpret complex data. These are objective non-clinical tests with predefined pass/fail criteria.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. This submission is for a physical medical device (transseptal needle) and does not involve AI, image interpretation, or human readers in an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an algorithmic or AI-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests performed, the "ground truth" refers to predefined engineering specifications, material properties standards, and biocompatibility standards. For example, for "Air and liquid leakage," the ground truth is an established standard for permissible leakage, or zero leakage. For "Tensile" testing, it would be a specified tensile strength range.
The sample size for the training set:
- This is not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- This is not applicable. As above, there is no training set for this type of device submission.

Summary

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Image /page/0/Picture/21 description: The image shows the logo for Greatbatch Medical. The logo consists of a circular arrangement of six hexagons, with the text "Greatbatch" on the right side of the hexagons. Below the word "Greatbatch" is the word "Medical."

510(k) Summary

DEC 1 9 2012

Submitter's Name/Address:

Contact Person:

Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441

K122832

Denise Thompson Sr. Regulatory Affairs Specialist Tel: 763-951-8254 Fax: 716-759-5040 dthompson@greatbatchmedical.com

Date Prepared:

Trade Name: Common Name: Classification Name: Product Code: Regulation: Classification Panel:

September 14th, 2012

MobiCath™ Transseptal Needle Transseptal Needle Trocar DRC Class II 21 CFR 870.1390 Cardiovascular

Predicate Device:

MobiCath™ Transseptal Needle (K111644)

Device Description:

Intended Use:

The MobiCath Transseptal Needles are used to create the primary puncture in the interatrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

Comparison to Predicate Device:

Greatbatch Medical proposes using an alternate stopcock for the MobiCath Trasseptal Needles. The current stopcock has been discontinued by the supplier. A similar stopcock has been tested as a replacement. A few minor design changes are required for the stopcock to interface with the handle components. In addition, a few manufacturing improvements have been proposed.

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The Intended Use and Indications for Use for the MobiCath Transseptal Needles have not changed.

The fundamental scientific technology of the MobiCath Transseptal Needles has not changed. The proposed modifications do not change the needle cannula or stylet, or the manner in which the needle punctures the inter-atrial septum.

The surgical approach and procedure have not changed.

The device use environment has not changed. The device is still intended to be used under prescription use by trained physicians in a surgical setting.

The overall device design has not changed. The device still consists of a cannula, handle, stopcock and stylet and these components continue to interact in the same manner. The proposed device changes only impact the dimensions and the material formulations of the stopcock and interfacing handle components.

Summary of Testing:

The following non-clinical tests were performed for the design changes to the MobiCath Transseptal Needle:

Design Verification Bench: ●
- Visual & Dimensional Inspection O
- Functional Testing o
- Tensile o
- o Torque
- Stopcock gauging ಂ
- Air and liquid leakage 0
- Stopcock separation force ಂ
- Stopcock resistance to override 0
- Stopcock ease of assembly o
- Stopcock stress cracking o
- Stylet to stopcock retention force o
- Stylet insertion through needle ಂ
Biocompatibility Testing .
- Cytotoxicity o
- Sensitization o
- Intracutaneous Reactivity ೦
- Acute Systemic Injection ಂ
- Materials Mediated Rabbit Pyrogenicity 0
- Hemocompatibility 0
- Hemolysis o
- Partial Thromboplastin Time o
- Platelet and Leukocyte Counts 0
- Complement Activation C3a and SC 5b-9 0
Package Distribution Testing
Shelf Life

Image /page/1/Picture/34 description: The image shows the logo for Greatbatch Medical. The logo consists of a circular arrangement of six smaller, solid shapes, resembling a stylized flower or gear. To the right of this symbol is the text "Greatbatch" in a bold, sans-serif font, with the word "Medical" appearing directly below it in a smaller font size.

Appendix D - Page 2 of 3

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Sterilization Rationale .
EtO Residual Testing

Conclusion:

Failure Modes and Effect Analysis was used to identify the performance parameters potentially affected by the design modifications. The risks were addressed through verification and validation activities. The results from these activities demonstrate that the risks have been mitigated and that no new safety or efficacy issues were raised.

· Greatbatch Medical considers the modified device to be substantially equivalent to the predicate device.

Image /page/2/Picture/6 description: The image contains the logo for Greatbatch Medical. The logo consists of a circular arrangement of smaller, stylized shapes on the left, followed by the text "Greatbatch" in a bold, sans-serif font. Below "Greatbatch" is the word "Medical" in a smaller font size. The overall design is simple and professional, likely representing a company in the medical field.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

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

DEC 1 9 2012

Greatbatch Medical Attention: Denise Thompson Sr. Regulatory Affairs Specialist 2300 Berkshire Lane North Minneapolis, MN 55441

Re: K122832

Trade/Device Name: MobiCath Transseptal Needle Regulation Number: 21 CFR 870.1390 Regulation Name: Cardiovascular devices - Trocar Regulatory Class: Class II Product Code: DRC Dated: November 20, 2012 Received: November 28, 2012

Dear Ms. Thompson:

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 mav 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Denise Thompson

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.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/ReportalProblem/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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Matthew G. Hillebrenner

Pro

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

Enclosure

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1.4 Indications for Use Statement

510(k) Number (if known): K12283

Device Name: MobiCath Transseptal Needle

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

urs Heele

(Division Sign-Off)
Division of Cardiovascular Devices

K122832 510(k) Number

Page 1 of 1

Page 15 of 42

Regulation Number and Section

§ 870.1390 Trocar.

(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.