Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. preintra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemormage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.

Device Description

The Medtronic PS Medical Becker EDMS is indicated for the draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space. The Becker EDMS is substantially equivalent in indications, materials of fabrication, performance characteristics and design specifications as compared with the predicate device, Codman External Drainage System II.

The materials utilized in the Becker EDMS are not substantially different to those used in currently marketed products. The Becker EDMS is comprised of a nondistensible blue striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, three non-latex iniection sites, and a removable drainage bag with approximate volumetric graduations and microbial filter. A graduated 50 cc flow chamber with drip former and conical bottom and locking bracket is included on the main system section.

AI/ML Overview

Here's an analysis of the provided text regarding the Medtronic PS Medical Becker External Drainage and Monitoring System (EDMS), focusing on acceptance criteria and the study proving its compliance.

It's important to note that the provided text is a 510(k) premarket notification summary from the FDA. This type of submission primarily focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than presenting a full clinical trial establishing novel safety and effectiveness. Therefore, many of your requested criteria (like sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance details) are typically not explicitly detailed in a 510(k) submission focused on substantial equivalence. The "study" here is essentially the comparison to the predicate device and the assertion of equivalent performance and indications.

Analysis of Acceptance Criteria and Device Performance for Medtronic PS Medical Becker EDMS

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (Implicit from Substantial Equivalence Claim)
Indications for Use	Equivalent to Codman External Drainage System II (K902257, K920938)	The Becker EDMS has expanded indications but is considered equivalent to the predicate's purpose of draining and monitoring CSF to reduce ICP. New indications include monitoring CSF chemistry/cytology/physiology, temporary drainage for infected shunts, specific conditions (severe head injury, subarachnoid hemorrhage, Reyes syndrome, hydrocephalus, intracranial hemorrhage), and evaluation for space-occupying lesions. The FDA deemed these acceptable within the scope of substantial equivalence based on the predicate.
Material Composition	Not substantially different from predicate device.	Materials utilized are "not substantially different to those used in currently marketed products" (including the predicate).
Performance Characteristics	Equivalent to Codman External Drainage System II	Asserted to be substantially equivalent. Functionality (draining, monitoring CSF flow from ventricles/lumbar subarachnoid space) is equivalent.
Design Specifications	Equivalent to Codman External Drainage System II	Asserted to be substantially equivalent. Closed system design, specific components (nondistensible patient line, stopcock, mounting panel, injection sites, drainage bag with microbial filter, flow chamber with drip former and locking bracket) are presented without specific quantifiable performance targets, but as equivalent in function and design to the predicate.
Safety	Equivalent to predicate device.	Asserted to be safe, indicated by its substantial equivalence claim, and compliance with general controls (annual registration, GMP, labeling, etc.).
Effectiveness	Equivalent to predicate device.	Asserted to be effective, indicated by its substantial equivalence claim.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable/Not specified. This is a 510(k) submission based on substantial equivalence, not a clinical study with a distinct "test set" of patients in the typical sense. Performance is inferred from comparison to a predicate device and existing knowledge about the technology.
Data Provenance: The "data" primarily comes from "predicate device product labeling" and the general understanding of ICP monitoring devices that have been "in widespread use" since 1973. There is no mention of specific patient data (retrospective or prospective) used to test the Becker EDMS directly against human outcomes within this document. The "provenance" is largely regulatory and comparative.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable/Not specified. Since there isn't a "test set" in the context of a new clinical performance study, there's no mention of experts establishing ground truth for such a set.
Qualifications of Experts: The document mentions "input from neurosurgeons" in the development of the device design. These neurosurgeons would be qualified clinical users of such devices, but they were involved in design input, not typically in establishing "ground truth" for a discrete test set.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No formal adjudication method involving a test set of cases is described. The FDA's review process itself serves as a form of "adjudication" of the substantial equivalence claim.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is not a type of study typically performed or required for a 510(k) submission for a device like this. It is a physical device for drainage and monitoring, not an AI or imaging diagnostic tool where reader performance is a primary outcome.
Effect Size of AI vs. Without AI Assistance: Not applicable. The device does not involve AI.

6. Standalone Performance Study

Standalone Performance Study: No explicit standalone clinical study is described. The core of the submission is demonstrating equivalence to a predicate device already on the market. While the device itself is "standalone" in its function, its performance is "proven" by comparison and assertion of similar physical and functional characteristics to a known, established device. Performance validation would typically involve bench testing for sterility, fluid dynamics, material compatibility, etc., but not a clinical standalone study against human outcomes as would be seen for a novel therapeutic or diagnostic.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Codman External Drainage System II), as well as the long-standing understanding of ICP monitoring and CSF drainage as described in literature since 1973. The Becker EDMS's performance is asserted to be equivalent to this established standard, rather than being independently validated against pathology or patient outcomes data in this specific filing.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not specified. This is not an AI/machine learning device. No "training set" in that sense is mentioned.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable. As there is no training set mentioned, this question does not apply.

Summary of the "Study" Proving Acceptance:

The "study" proving the device meets acceptance criteria is primarily an argument for substantial equivalence based on:

Direct comparison of the Medtronic PS Medical Becker EDMS device's design, materials, and intended use with the predicate Codman External Drainage System II. Tables 1 and 2 (though not provided in the excerpt) would detail these comparisons.
Assertion of equivalent performance characteristics based on the similarities in design and materials.
Reference to the accepted safety and effectiveness of the predicate device as demonstrated in its own product labeling and commercial distribution history.
The historical context that ICP monitoring devices have been in "widespread use" since 1973, suggesting established clinical benefit and technological understanding.
Input from neurosurgeons during the device's development phase.

The FDA's review and ultimate 510(k) clearance (K984053) signifies their agreement that Medtronic PS Medical successfully demonstrated this substantial equivalence, allowing the device to be marketed. This process does not typically involve the type of detailed clinical study data often associated with new technology or drugs.

Summary

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Safety and Effectiveness Summary ll.

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Determination of substantial equivalence

The ICP monitoring device and method were first described in an article published in 1973. Over the years the device has come into widespread use.

Medtronic PS Medical has, with input from neurosurgeons, developed a device design, which is considered to be equivalent to the predicate Codman External Drainage System II (K902257, 19249383 The Medtronic PS Medical Becker EDMS is a complete closed system indicated for the draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space.

K910938 - listed incorrectly throughout Medtronic PS Medical considers the Medtronic PS Medical Becker EDMS to be substantially equivalent to the Codman External Drainage System II (K902257, K920938), currently in commercial distribution. The predicate device is used for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing and controlling increased intracranial volume and pressure when the insertion of a permanent internal shunt is not needed. A comparison of the Codman External Drainage System II and the Medtronic PS Medical Becker EDMS is included in Tables 1 and 2.

Medtronic PS Medical considers the Becker EDMS to be safe, effective and substantially equivalent in indications, physical characteristics and performance to the noted predicate device. Evidence of this is provided in predicate device product labeling (Attachment 2).

Device Name

Medtronic PS Medical Becker External Drainage and Monitoring System (Becker EDMS).

Predicate Device(s)

Codman External Drainage System II (K902257, K920938)

Device Description

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flow chamber with drip former and conical bottom and locking bracket is included on the main system section.

A comparison of the Becker EDMS and predicate device is provided in Table 1.

Intended Use

The Medtronic PS Medical Becker EDMS will be indicated for use as follows: "Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. preintra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemormage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions."

Draft Medtronic PS Medical product labeling and product literature for the Medtronic PS Medical Becker EDMS is included (Attachment 1).

Intended Use predicate device

The predicate device Codman External Drainage System II is indicated for use as follows:

"Use of the Codman External Drainage System II is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing and controlling increased intracranial volume and pressure when the insertion of a permanent internal shunt is not indicated."

Product literature for the predicate Codman External Drainage System II is included (Attachment 2).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 FEB

Mr. Jeffrey Henderson Vice President, Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117-5500

Re: K984053 Becker External Drainage and Monitoring System Regulatory Class: II Product Code: JXG November 3 1998 Dated: Received: November 6, 1998

Dear Mr. Henderson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jeffrey Henderson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell S. Page

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Becker External Drainage and Monitoring System (EDMS)

510(k) Number (if known):

984053

Indications for Use:

"Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. preintra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemorthage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions."

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Nino Panzera for J2P

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ 3 3 40 3

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

(optional format 1-2-96)

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).