ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard IAT equipment which processes the blood retrieved from ProCellTM prior to reinfusion into the patient (autologous blood transfusion).

Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing.

Device Description

The ProCell™ Surgical Sponge - Blood Recovery Unit ("ProCell") automates the manual hand-wringing process to extract blood from surgical sponges. The ProCell unit consists of three components 1) a piston Lid, 2) a perforated Sponge Basket, and 3) a Reservoir. The Sponge Basket is inserted into the Reservoir, and the piston Lid is placed on the top opening of the Reservoir. Through the use of standard Operating Room vacuum suction, blood is extracted from the sponges and is collected in the Reservoir.

ProCell is used in conjunction with standard intraoperative autotransfusion devices (IAT) which must process the blood retrieved from ProCell prior to reinfusion into the patient. ProCell functions as a blood collection device only, is not a blood storage container, and does not filter or otherwise process the recovered blood. The recovered blood from ProCell is not intended to be infused directly back into the patient.

AI/ML Overview

The provided text describes the regulatory clearance for the ProCell Surgical Sponge-Blood Recovery Unit. While it lists various performance tests and standards compliance, it does not explicitly detail acceptance criteria in a table format with reported performance for device metrics. It also does not include information about studies involving human readers, ground truth establishment methods for training or test sets, or sample sizes specific to AI/algorithm development.

The document focuses on the mechanical and biocompatibility aspects of the device, rather than its performance in the context of an AI/ML algorithm. Therefore, many of the requested items related to AI/ML studies are not applicable or present in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria for device performance in terms of quantitative metrics for blood recovery efficiency or quality within this 510(k) summary. Instead, it lists areas where testing was conducted to ensure safety and functionality.

Inferred "Acceptance Criteria" represented by the standards:

Test Category	Implicit Acceptance Criteria / Standard Compliance	Reported Device Performance
Biocompatibility	- ISO 10993-1: Evaluation & testing within a risk management process- ISO 10993-4: Selection of tests for interactions with blood- AAMI/ANSI/ISO 10993-5: Tests for in vitro cytotoxicity- ISO 10993-10: Tests for irritation and skin sensitization- ISO 10993-11: Tests for Systemic Toxicity- ISO 10993-12: Sample preparation and reference materials- USP NF36:2018 <85> Bacterial Endotoxins Test (USP Rabbit Test)- ASTM F2382-18: Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)- ASTM F2888-19: Platelet Leukocyte Count - In-Vitro Measure For Hemocompatibility- ASTM F756-17: Assessment of Hemolytic Properties of Materials	Device meets these standards, ensuring biocompatibility and hemocompatibility, as implied by the FDA clearance based on these tests.
Sterilization	- ISO 11137-1: Requirements for development, validation, and routine control of a sterilization process- ISO 11137-2: Establishing the sterilization dose- ISO 11737-1: Determination of a population of microorganisms on products- BS EN ISO 11737-2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process- USP NF36:2018 <151> Pyrogen Test	Device meets these standards, ensuring it is sterile and non-pyrogenic.
Packaging & Shelf Life	- ASTM D4169-16: Performance testing of shipping containers and systems- ASTM F88/F88M-15: Seal Strength of Flexible Barrier Materials- ASTM F2096-11: Detecting gross leaks in packaging by internal pressurization- ANSI/AAMI/ISO 11607-1: Packaging for terminally sterilized medical devices- ASTM F1980-16: Accelerated Aging of Sterile Barrier Systems- ASTM D5276-98(2017): Drop Test of Loaded Containers by Free Fall- ASTM D642-15: Determining Compressive Resistance of Shipping Containers- ASTM D999-08: Vibration Testing of Shipping Containers- ASTM F4728-17: Random Vibration Testing of Shipping Containers	Device meets these standards, ensuring packaging integrity and shelf life under various transport and storage conditions.
Functional & Structural Integrity	- Not explicitly detailed as separate standards in the provided text, but implied by the "Functional and structural integrity" and "Operational performance" test categories. This would typically involve physical durability, leak testing, and proper operation of its mechanical components (piston lid, sponge basket, reservoir).	Device performs as intended for blood extraction from sponges. The FDA clearance confirms that the device has demonstrated it will perform per its intended use based on these tests.
Red Blood Cell Viability	- "Red blood cell viability" was a specific test conducted. (No explicit standard mentioned in this section for this specific test, but likely covered under hemocompatibility standards like ISO 10993-4 and ASTM F756-17)	Information on the specific metrics (e.g., % viability) and acceptance limits is not provided in this summary, but the clearance implies acceptable viability.

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

The document does not provide details on sample sizes for test sets in the context of clinical or AI/ML performance. The "testing" mentioned is laboratory-based (biocompatibility, sterilization, packaging, functional), and the sample sizes for these types of tests would be determined by the specific standards and protocols involved, not typically reported in this summary document. Data provenance is not applicable here as these are not clinical data studies.

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)

Not applicable. This device is not an AI/ML diagnostic tool that requires expert-established ground truth for image or data interpretation. Its function is mechanical blood recovery.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the types of tests conducted (biocompatibility, sterilization, etc.), the "ground truth" is typically established by physical/chemical laboratory measurements and adherence to specified performance limits defined in the referenced ISO and ASTM standards. For example, for sterility, it's the absence of microbiological growth, which is a definitive laboratory outcome. For hemocompatibility, it's compliance with established limits for coagulation times or hemolysis.

8. The sample size for the training set

Not applicable. This device does not involve AI/ML and therefore does not have a training set.

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

Not applicable. This device does not involve AI/ML.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 1, 2020

ProCell Surgical, Inc. % Sharyn Orton Senior Consultant MEDIcept Inc. 200 Homer Ave Ashland, Massachusetts 01721

Re: K193361

Trade/Device Name: ProCell Surgical Sponge-Blood Recovery Unit Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: April 28, 2020 Received: April 30, 2020

Dear Sharyn Orton:

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel for Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193361

Device Name

ProCell™ Surgical Sponge - Blood Recovery Unit

Indications for Use (Describe)

ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of intraoperative autotransfusion or IAT.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the ProCell logo. The logo consists of a stylized drawing of a cell on the left and the word "ProCell" in blue on the right. The word "ProCell" is written in a modern, sans-serif font. The letters are all capitalized, and the "C" is slightly larger than the other letters. There is a small "TM" symbol in the upper right corner of the word "ProCell".

Traditional 510(k) Summary as required by 21CFR 807.92(a)

A) Submitted by:	ProCell Surgical, Inc.19 Menin RoadToronto, Ontario M6C3J1Canada
Contact:	Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer Ave.Ashland, MA 01721401-330-8264
Date Prepared:	December 2, 2019
B) Classification Name:	Apparatus, Autotransfusion
Proprietary Name:	ProCell™ Surgical Sponge – Blood Recovery Uni
Common/Usual Name:	ProCell™ Surgical Sponge - Blood Recovery Uni
Device Regulation:	21 CFR 868.5830
Class:	II
Product Code:	CAC
Review Panel:	Anesthesiology

C) Predicate:

K140205 Teleflex Medical, Inc. Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System

D) Device Description:

{4}------------------------------------------------

E) Intended Use/Indications for Use
ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of intraoperative autotransfusion or IAT.

ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard IAT equipment which processes the blood retrieved from ProCell™ prior to reinfusion into the patient (autologous blood transfusion).

F) Technological Characteristics and Substantial Equivalence Comparison to Predicate Device The ProCell device is substantially equivalent to the Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System (Pleur-Evac) predicate device in that both devices are an accessory to an Autotransfusion Apparatus regulated under 21 CFR 868.5830, Product Code CAC and intended for blood collection only. Both devices are single case-use sterile devices that operate through a vacuum assist and do not process the collected blood. Both devices must have the collected blood sent to the autotransfusion equipment for processing prior to patient reinfusion.
The ProCell device is different from the Pleur-Evac predicate device in that the Pleur-Evac is an accessory to a closed chest drainage system which is attached though patient tubing from the device to the patient's chest tube during immediate post-operative period for blood collection to prevent complications related to fluid accumulation, while the ProCell device is a self-contained unit which extracts and collects blood from surgical sponges. The Pleur-Evac is initially setup at the operating room table but once connected to the patient, is passed off the table and handled in a non-sterile fashion. The internal parts and contents remain sterile when the closed system is maintained. ProCell remains on the operating room instrument table (sterile field) for the duration of the procedure and can be used multiple times throughout the case.
G) Performance Testing and Standards Compliance
The following testing has been conducted:
Biocompatibility
Sterilization ●
Packaging and shelf life
Functional and structural integrity
Operational performance ●
. Red blood cell viability

{5}------------------------------------------------

Testing has been conducted in compliance with the following standards:

ISO 10993-1 Fifth Edition 2018-08. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- o Consistent with ANSI/AAMI/ISO 10993-1:2009 (R)2013
ISO 10993-4: 2017, Biological evaluation of medical devices--Part 4: Selection of ● tests for interactions with blood
AAMI/ANSI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices --Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11: 2017, Biological Evaluation of Medical Devices - Part 11: Tests For Systemic Toxicity
ISO 10993-12: 2012, Biological Evaluation of Medical Devices. – Part 12: Sample preparation and reference materials. As appropriate, standard surface area extraction ratios (for the devices) were used.
41 USP NF36:2018 <85> Bacterial Endotoxins Test (USP Rabbit Test)
ASTM F2382-18, Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
. ASTM F2888-19 Standard Practice For Platelet Leukocyte Count - An In-Vitro Measure For Hemocompatibility Assessment Of Cardiovascular Materials
. ASTM F756-17. Standard Practice for Assessment of Hemolytic Properties of Materials
. ISO 15223-1:2016. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
. ISO 11137-1:2006/A1:2013, Sterilization of health care products -- radiation -- part 1: requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013, Sterilization of health care products - radiation - part 2: establishing the sterilization dose
ISO 11737-1: 2018, Sterilization Of Health Care Products - Microbiological Methods - Part 1: Determination Of A Population Of Microorganisms On Products
. BS EN ISO 11737-2: 2009. Sterilization Of Medical Devices - Microbiological Methods - Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process
- o Consistent with ISO 11737-2:2009
41 USP NF36:2018 <151> Pyrogen Test
ASTM D4169-16, Standard practice for performance testing of shipping containers and systems
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F2096-11, Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test)
ANSI/AAMI/ISO 11607-1: 2019, Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems o Consistent with ISO 11607-1:2019

ProCell™ Surgical Sponge – Blood Recovery Unit Traditional 510(k) Premarket Notification

{6}------------------------------------------------

ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems ● for Medical Devices
ASTM D5276-98(2017), Standard Test Method for Drop Test of Loaded Containers by Free Fall
ASTM D642-15, Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads
ASTM D999-08, Standard Test Methods for Vibration Testing of Shipping Containers
ASTM F4728-17, Standard Test Method for Random Vibration Testing of Shipping Containers

H) Conclusion

The ProCell Surgical Sponge-Blood Recovery Unit is substantially equivalent to the Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System. The ProCell Surgical Sponge-Blood Recovery Unit has demonstrated that it will perform per its intended use.

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).