Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

• K Number: K201118
• Device Name: Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
• Manufacturer: Medtronic, Inc.
• Date Cleared: 2020-05-26 ( 29 days)
• Product Code: GWM HCA
• Regulation Number: 882.1620

Intended Use

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce ICP, e.g., pre-, intra- or postoperative. 2. Monitor CSF chemistry, cytology, and physiology. 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of ICP is indicated in selected patients with: 1. Severe head injury. 2. Subarachnoid hemorrhage graded III, IV or V preoperatively. 3. Reyes syndrome or similar encephalopathies. 4. Hydrocephalus. 5. Intracranial hemorrhage. 6. 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 Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

Predicate Devices

K983799

Reference Devices

K983799

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and physical aspects of a drainage and monitoring system, with no mention of AI or ML technologies.

Therapeutic

Yes

The device aids in reducing ICP and is used for temporary CSF drainage in patients with infected cerebrospinal fluid shunts, which are therapeutic maneuvers.

Diagnostic

Yes

The document explicitly states "Monitoring of ICP is indicated in selected patients..." and lists several conditions for which monitoring is used, such as "Severe head injury," "Subarachnoid hemorrhage," and "Hydrocephalus." It also mentions "Monitor CSF chemistry, cytology, and physiology." These uses directly align with the definition of a diagnostic device, which is used for identifying or monitoring diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a single use drainage system, a reusable blue pole clamp, and a laser level accessory, all of which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Function: The Exacta External Drainage and Monitoring System (EDMS) is designed for the drainage and monitoring of cerebrospinal fluid (CSF) flow directly from the patient's body (lateral ventricles or lumbar subarachnoid space). It's a system for managing and observing a physiological process within the body, not for analyzing a sample in vitro.
• Intended Use: The intended uses listed are focused on reducing ICP, monitoring CSF chemistry/cytology/physiology in situ (though samples could be collected for later IVD testing), providing temporary drainage, and monitoring ICP in various clinical conditions. These are all related to managing the patient's condition directly.
• Device Description: The description details a system for collecting and measuring fluid flow, not for performing analytical tests on a sample.

While the system can be used to collect CSF samples that could then be used for IVD testing, the device itself is not performing the diagnostic test in vitro. It's a system for managing and monitoring a bodily fluid in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

• 1. Reduce ICP, e.g., pre-, intra- or postoperative.
• 2. Monitor CSF chemistry, cytology, and physiology.
• 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

Monitoring of ICP is indicated in selected patients with:

• 1. Severe head injury.
• 2. Subarachnoid hemorrhage graded III, IV or V preoperatively.
• 3. Reves syndrome or similar encephalopathies.
• 4. Hydrocephalus.
• 5. Intracranial hemorrhage.
• 6. 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.

Product codes

GWM, HCA

Device Description

The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications.
The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lateral ventricles or lumbar subarachnoid space.

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)

The performance testing included dimensional verification and design verification testing of the laser level. This testing demonstrated compliance to electrical standards IEC 60601-1:2005 + AMD1:2012 and IEC 60601-1-2:2014 / EN 60601-1-2:2015. Laser testing was also completed in compliance with IEC/EN 60825-1:2014. The successful results of these tests demonstrated that the changes do not raise questions of safety and effectiveness.

Bench Performance Tests:

• Mechanical Strength: Verified laser does not present a safety hazard after push test, impact test and dropping. Results: The laser level device met the acceptance criteria for mechanical strength.
• Beam Uniformity: Measured and recorded the beam uniformity to determine offset. Results: The laser level device met the acceptance criteria for beam uniformity.
• Laser Accuracy: Calculated and recorded the laser accuracy at a set distance. Results: The laser level device met the acceptance criteria for laser accuracy.
• Laser Safety: Verified laser power output complies with exposure limits for Class 3R Laser. Results: The laser level device met the acceptance criteria for laser safety.
• Auto Shut Off: Measured and recorded the time laser is "on" after activation. Results: The laser level device met the acceptance criteria for auto shut off.

Animal Performance Data: Not required for proposed modifications to the laser level.
Clinical Performance Data: Not required for proposed modifications to the laser level.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K983799

Reference Device(s)

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

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 26, 2020

Medtronic, Inc. Jen Correa Program Manager, Regulatory Affairs 5290 California Avenue Irvine, California 92617

Re: K201118

Device Name: Exacta External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM, HCA Dated: April 24, 2020 Received: April 27, 2020

Dear Jen 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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng -S

Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201118

Device Name

Exacta External Drainage and Monitoring System (EDMS)

Indications for Use (Describe)

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

• 1. Reduce ICP, e.g., pre-, intra- or postoperative.
• 2. Monitor CSF chemistry, cytology, and physiology.
• 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

Monitoring of ICP is indicated in selected patients with:

• 1. Severe head injury.
• 2. Subarachnoid hemorrhage graded III, IV or V preoperatively.
• 3. Reves syndrome or similar encephalopathies.
• 4. Hydrocephalus.
• 5. Intracranial hemorrhage.
• 6. 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.

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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510(k) Summary

Medtronic Exacta External Drainage and Monitoring System (EDMS)

510(k) Summary

May 19, 2020

• I. Medtronic Neurosurgery Company: 5290 California Ave Irvine, CA 92617 USA Contact: Jen Correa Program Manager, Regulatory Affairs [e-mail] Telephone Number: 949-297-5494

II. Establishment Registration Number: 3015531529

• III. Proprietary Trade Name: Exacta External Drainage and Monitoring System (EDMS)
• IV. Regulator Classification: II

V. Primary Classification

Name: Intracranial pressure monitoring device Product code: GWM Regulation: 21 CFR 882.1620

Secondary Classification

Name: Ventricular Catheter Product code: HCA Regulation: 21 CFR 882.4100

• VI. Product Description: The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications.
  The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the svstem to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

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VII. Indications for Use:

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

• 1. Reduce ICP, e.g., pre-, intra- or postoperative.
• 2. Monitor CSF chemistry, cytology, and physiology.
• 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

Monitoring of ICP is indicated in selected patients with:

• 1. Severe head injury.
• 2. Subarachnoid hemorrhage graded III, IV or V preoperatively.
• 3. Reyes syndrome or similar encephalopathies.
• 4. Hydrocephalus.
• 5. Intracranial hemorrhage.
• 6. 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.

• VIII. Summary of the Technological Characteristics: The subject laser level device shares the same features and use as the predicate laser level. The rest of the Exacta EDMS device has the same technological characteristics as the predicate device.

	Subject Device	Predicate Device
		K983799
Intended
use/Indications
for Use	Draining and monitoring of CSF flow from
the lateral ventricles or lumbar
subarachnoid space is indicated in selected
patients to:

1. Reduce ICP, e.g., pre-, intra- or
   postoperative.
2. Monitor CSF chemistry, cytology, and
   physiology.
3. Provide temporary CSF drainage in
   patients with infected cerebrospinal
   fluid shunts.
   Monitoring of ICP is indicated in selected
   patients with:
4. Severe head injury.
5. Subarachnoid hemorrhage graded III,
   IV or V preoperatively.
6. Reyes syndrome or similar
   encephalopathies.
7. Hydrocephalus. | Same |
   | | Subject Device | Predicate Device |
   | | | K983799 |
   | | 5. Intracranial hemorrhage. | |
   | | 6. 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. | |
   | Operating
   Principle | External drainage is temporary drainage of
   cerebrospinal fluid (CSF) from the lateral
   ventricles of the brain, or the lumbar space
   of the spine, into an external collection
   bag. The Exacta EDMS drains CSF by
   using a combination of gravity and
   intracerebral pressure. The drainage rate
   depends on the height at which the system
   is placed relative to the patient's anatomy. | Same |
   | Materials | There are no materials with direct patient
   contact | Same |
   | Laser Level
   Accessory
   Features and
   Use | Battery-operated reusable non-sterile
   accessory that is used to align the external
   reference point with the zero reference
   point of the EDMS device. | Same |
   | Laser Level
   Accessory
   Design | Level Bubbles: Two, located at top and
   bottom of device | Level Bubbles: Same |
   | | Maximum Output: