CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) by CHARTER MEDICAL, LTD.

The provided text describes the 510(k) submission for the Charter Medical, Ltd. 40 Micron Filter (Code MP450). It details the comparison of the new device to a predicate device to establish substantial equivalence.

Based on the provided information, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	The device is substantially equivalent (as defined in Section 360c(l)(1)(A)(ii) of the Federal Food, Drug and Cosmetic Act) in performance to the predicate device. This is determined by flow rate, effect of filtration on blood constituents, and hold-up volume.	The device was determined by FDA to be substantially equivalent to the PALL Biomedical Products Company's SQ™40S 40-Micron Screen Filter (K811985). This determination was based on comparative studies assessing flow rate, effect of filtration on blood constituents (white blood count, red blood count, hemoglobin, and hematocrit), and hold-up volume.
Material Biocompatibility	Materials used to manufacture the device were assessed in respect to biocompatibility using methods specified in ISO Standard 10993-1.	Materials were found to be acceptable for intended use based on assessment using ISO Standard 10993-1.
Physical Testing	Housing integrity, media integrity, filter cleanliness, removal characteristics (microaggregates and particulate debris), and security of attachments.	Physical testing supported that the device is suitable for its intended use, covering aspects like housing integrity, media integrity, filter cleanliness, removal characteristics, and security of attachments.

Study Details:

The information provided describes a comparative study to demonstrate substantial equivalence to a predicate device. It is not a clinical study involving patients or a study with human readers assessing AI performance in a diagnostic context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document refers to "comparative studies" and "physical testing" but does not provide specific sample sizes for these tests.
Data Provenance: Not explicitly stated. It's implied these are laboratory or bench testing results conducted by Charter Medical, Ltd. (USA), but the specific location of the tests or if any external data was used is not mentioned. They are likely prospective tests conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. The ground truth for this device approval revolves around objective measurements of performance characteristics (flow rate, blood constituent impact, hold-up volume, biocompatibility, physical integrity) against a predicate device and established standards. It does not involve expert interpretation or consensus on a diagnostic outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert opinions. The assessment relies on direct measurement and comparison of physical and performance characteristics.

5. 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

MRMC Comparative Effectiveness Study: No. This is a medical device (filter) submission, not an AI-based diagnostic tool. Therefore, an MRMC study assessing human reader performance with or without AI assistance is not relevant and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable in the context of an AI algorithm. The "standalone performance" of the device in this case refers to its functional characteristics (filtration, flow rate, biocompatibility) as measured in the comparative studies and physical tests. These are inherent to the device itself, without human intervention as part of its primary function, other than its proper installation and operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The ground truth is primarily based on:
- Objective measurements: Of device characteristics like flow rate, hold-up volume, white blood count, red blood count, hemoglobin, hematocrit.
- Established standards: ISO Standard 10993-1 for biocompatibility.
- Comparison to a predicate device: The performance of the predicate device (PALL Biomedical Products Company SQ™40S 40-Micron Screen Filter) serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a medical device (filter) submission, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device submission.

Summary

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AUG 30 1999

Image /page/0/Picture/1 description: The image shows the logo for Charter Medical. The logo consists of the word "CharterMedical" in a bold, sans-serif font. A black, crescent-shaped graphic wraps around the left side of the word, partially obscuring the "C" in "Charter."

K990310
Charter Medical, Ltd.

3948-A West Point Boulevard Winston Salem, NC 27103 Telephone 336 768-6447 Facsimile 336 774-1750

1805 Swarthmore Avenue Lakewood, NJ 08701 Telephone 732 901-9400 Facsimile 732 901-9405

December 7, 1998 Page 1 of 2

SECTION 1.0 - 510(k) SUMMARY Charter Medical, Ltd. 40 Micron Filter (Code MP450)

Applicant Name Charter Medical, Ltd.

FDA Registration Number

2246665

Address

Lakewood, NJ 08701

Contact Person

Telephone

Quality Assurance

(732) 901-9400, Extension 17 (voice mail),

Extension 23 (operator)

1805 Swarthmore Avenue

K. Alice Preville, Director

FAX

(732) 901-9405

Proposed Device

Nomenclature

a. Trade Name Charter Medical, Ltd. MP450 (40 Micron Filter) Trademark is to be determined b. Common Name 40 Micron Filter 40 micron filter offered both as a stand alone device and as Description an integral component of a Y-Blood Administration Set. Intended Use To remove microaggregates and particulate debris from whole blood and red blood cells (RBCs) during infusion. Predicate Device SQ™40S 40-Micron Screen Filter manufactured by PALL Biomedical Products Company was determined by FDA to be substantially equivalent in July 1981 (Ref: K811985)

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Summary of Technological Characteristics of New Device to Predicate Device

The device is substantially equivalent (as defined in Section 360c(l)(1)(A)(ii) of the Federal Food, Drug and Cosmetic Act) in performance to, in that it is as safe and effective as, the predicate device, as determined by flow rate, effect of filtration on blood constituents (white blood count, red blood count, hemoglobin, and hematocrit), and hold-up volume.

Materials used to manufacture the device were assessed in respect to biocompatibility using methods specified in ISO Standard 10993-1 and were found to be acceptable for intended use.

In addition to the referenced comparative studies, physical testing (i.e. housing integrity, media integrity, filter cleanliness, removal characteristics and security of attachments) support that the device is suitable for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. David Heagle R & D Manaqer Charter Medical Limited 1805 Swarthmore Avenue Lakewood, New Jersey 08701

Re : K990310 Charter Medical, · Ltd. MP450 (40 Micron Trade Name: Filter) Regulatory Class: II Product Code: CAK Dated: August 9, 1999 Received: August 12, 1999

Dear Mr. Heagle:

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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will Verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Heagle

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 requlations.

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 markets 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) 594-4692. 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,

Timothy A. Ulatowski

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K990310

Page 1 of 1

510(k) Number ( if known ): __________________________________________________________________________________________________________________________________________________

Device Name: Charter Medical, Ltd. 40 Micron Filter (Code MP450)

Indications for Use:

Single use device for the removal of microaggregate and particulate debris from whole blood and red blood cells (RBCs) during infusion.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEEDED) Concurrent of CDRH, Office of Device Evaluation (ODE)

Patricia Cucente

(Division Sign-Off) Ovesson of Dental, Infection Control, and General Hospital Devic 510(k) Number _

V Prescription Use (per 21 CFR 801.109) OR

Over the Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.