Dr. PRP

BK230818 · YTS Global Inc. Springfield, VA · ORG · May 31, 2023 · Hematology

Device Facts

• Record ID: BK230818
• Device Name: Dr. PRP
• Applicant: YTS Global Inc. Springfield, VA
• Product Code: ORG · Hematology
• Decision Date: May 31, 2023
• Decision: SESE
• Regulation: 21 CFR 864.9245
• Device Class: Class 2

Indications for Use

The Dr.PRP is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.

Device Story

Dr.PRP is a sterile, single-use, disposable concentrating unit (20 ml capacity) made of medical-grade polymer and elastomer; used at point-of-care by clinicians. Device accepts peripheral blood sample; utilizes swing-rotor general-purpose centrifuge to separate blood components based on density. Process yields autologous platelet-rich plasma (PRP). Clinician mixes PRP with autograft/allograft bone to improve handling characteristics for application to bony defects. Benefits include rapid, safe preparation of autologous PRP to assist in bone graft application.

Clinical Evidence

Bench testing only. In vitro performance study (n=20 for cellular composition, n=6 for platelet function) compared subject device to predicate at 0 and 4 hours. Metrics included pH, p-selectin, HSR, aggregation, WBC, RBC, PLT counts, PLT recovery, and concentration factor. All parameters demonstrated substantial equivalence with 90% confidence intervals for the ratio of means within 0.8–1.25. Biocompatibility testing per ISO 10993-1 and bacterial endotoxin testing per ANSI/AAMI ST72 confirmed safety.

Technological Characteristics

Disposable concentrating unit (tube) composed of medical-grade polymer and elastomer. Principle of operation: density-based separation via centrifugation. Energy source: external general-purpose centrifuge. Sterilization: validated method. Biocompatibility: ISO 10993-1 compliant. Shelf-life: 3 years (ASTM/ISO standards).

Indications for Use

Indicated for patients requiring autologous platelet-rich plasma (PRP) preparation from peripheral blood for mixing with autograft or allograft bone to improve handling during orthopedic surgical procedures at the point of care.

Regulatory Classification

Identification

An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”

Predicate Devices

• GenesisCS Component Concentrating System (BK050055)

Submission Summary (Full Text)

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# 510(k) Summary

## I. SUBMITTER

| Date Prepared | 2023-05-24 |
| --- | --- |
| Submitter | YTS Global Inc. 7406 Alban Station Ct. Suite 108a Springfield, VA 22150, USA |
| Contact | Won Lee (b) (6) |
| Manufacture | Rmedica Co., Ltd. 2-Dong 709-Ho (Gasan-Dong, IT Castle) 98 Gasan digital 2-ro, Geumcheon-gu, Seoul, KR 08506 |

## II. DEVICE

| Name of Device | Dr.PRP |
| --- | --- |
| Common Name | Platelet and Plasma Separator for Bone Graft Handling |
| Product Code | ORG |
| Regulation Number | 21 CFR 864.9245 |
| Classification Name | Automated Blood Cell Separator |
| Device Class | Class II |
| Review Panel | Hematology |

## III. PREDICATE DEVICE

GenesisCS Component Concentrating System, BK050055

## IV. DEVICE DESCRIPTION

The Dr.PRP is provided as individually packaged sterile, single-use, disposable concentrating unit which is composed of medical grade polymer and elastomer. The concentrating unit has 20 ml of volume capacity and is designed to work with a swing rotor type general purpose centrifuge

## V. INDICATIONS FOR USE

The Dr.PRP is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The fundamental scientific technology, materials of construction, processing methods and mechanism of operation are similar between the subject Dr.PRP and predicate. Both devices are provided as sterile concentrating unit (tube), designed to concentrate and aid in separation of blood by density through the

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use of a centrifuge. Both devices include a single-use, disposable concentrating unit that is designed to accept a volume of blood, and then undergo centrifugal processing, in order to obtain platelet concentrate (PRP). Both devices have substantially same intended use. Dr.PRP is biocompatible and is composed of medical grade polymer and elastomer like its predicate. The table below summarizes the comparison of characteristics between the subject and predicate devices.

| Characteristic | Primary Predicate device (GenesisCS Component Concentrating System, BK050055). | Subject device (Dr.PRP) | Comparison |
| --- | --- | --- | --- |
| Intended Use | The GenesisCS Component Concentrating System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements | The Dr.PRP is designed to be used for the safe and rapid preparation of autologous platelet rich plasma from a small sample of blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics | Similar –Both devices are designed to be used for the safe and rapid preparation of autologous platelet rich plasma from a small sample of blood at the patient's point of care. |
| Component | Disposable concentrating unit (tube) packaged with syringes, blood draw needle and blood draw accessories | Disposable concentrating unit (tube) | Similar – subject does not include higher risk accessories like needle. This difference does not raise any new issue of substantial equivalence |
| Material | Medical grade polymers, elastomers and stainless steel suitable for use in medical devices | Medical grade polymer and elastomer suitable for use in medical devices | Similar – subject does not include higher risk accessories like needle. This difference does not raise any new issue of substantial equivalence |
| Principle of Operation | Separation of blood based on density | Separation of blood based on density | Identical |
| Method of Processing | Centrifugation | Centrifugation | Identical |
| Centrifuge Device | General purpose centrifuge | General purpose centrifuge | Identical |
| Usage | For single use only | For single use only | Identical |
| Sterile | Yes | Yes | Identical |

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## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Bench Testing – In vitro Performance Testing

two-sided 90% confidence interval for the ratio of test device mean to predicate device mean.

*a. Two-sided 90% confidence intervals for platelet function data at Time Point 0 hour.*

| Time Point 0 hour | pH | | p-selectin (resting) | | p-selectin (ADP) | | HSR | | Aggregation (collagen) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate |
| **Data** (n=6) | 7.3 | 6.9 | 11.0 | 10.9 | 50.8 | 51.9 | 91.6% | 95.6% | 67 | 57 |
| | 7.2 | 6.8 | 10.8 | 7.9 | 52.5 | 54.3 | 95.5% | 94.6% | 78 | 80 |
| | 7.3 | 6.8 | 8.8 | 11.9 | 53.1 | 53.3 | 94.4% | 93.4% | 47 | 59 |
| | 7.2 | 6.8 | 10.7 | 9.0 | 54.2 | 51.2 | 94.1% | 93.1% | 49 | 68 |
| | 7.3 | 6.8 | 9.1 | 8.8 | 49.2 | 48.4 | 93.3% | 96.3% | 86 | 48 |
| | 7.2 | 6.8 | 8.9 | 9.9 | 51.5 | 49.4 | 95.5% | 94.1% | 33 | 41 |
| **Mean** | 7.25 | 6.82 | 9.88 | 9.73 | 51.9 | 51.4 | 94.1% | 94.5% | 60.0 | 58.8 |
| **Ratio** | 1.064 | | 1.040 | | 1.010 | | 0.995 | | 1.044 | |
| **S.D.** | 0.008 | | 0.219 | | 0.036 | | 0.025 | | 0.401 | |
| **90% C.I.** | 0.005 | | 0.147 | | 0.024 | | 0.017 | | 0.269 | |
| **two-sided 90% C.I.** (0.8 ~ 1.25) | 1.06 ~ 1.07 | | 0.89 ~ 1.19 | | 0.99 ~ 1.03 | | 0.98 ~ 1.01 | | 0.77 ~ 1.31 | |
| | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | | - | |

*b. Two-sided 90% confidence intervals for platelet function data at Time Point 4 hours.*

| Time Point 4 hours | pH | | p-selectin (resting) | | p-selectin (ADP) | | HSR | | Aggregation (collagen) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate |
| **Data** (n=6) | 7.3 | 6.9 | 28.5 | 26.6 | 78.1 | 77.5 | 96.2% | 94.9% | 64 | 59 |
| | 7.2 | 6.8 | 26.3 | 29.3 | 78.8 | 79.5 | 96.6% | 95.7% | 64 | 58 |
| | 7.3 | 6.8 | 26.1 | 25.7 | 80.5 | 78.3 | 96.3% | 94.5% | 48 | 74 |
| | 7.2 | 6.8 | 31.1 | 24.2 | 77.4 | 77.6 | 96.1% | 96.1% | 58 | 64 |
| | 7.3 | 6.8 | 26.9 | 25.5 | 78.5 | 76.8 | 95.4% | 95.5% | 65 | 64 |
| | 7.2 | 6.8 | 28.6 | 26.6 | 77.8 | 78.5 | 97.7% | 97.3% | 52 | 54 |
| **Mean** | 7.25 | 6.82 | 27.9 | 26.3 | 78.5 | 78.0 | 96.4% | 95.7% | 58.5 | 62.2 |
| **Ratio** | 1.064 | | 1.067 | | 1.006 | | 1.008 | | 0.954 | |
| **S.D.** | 0.008 | | 0.126 | | 0.016 | | 0.008 | | 0.167 | |
| **90% C.I.** | 0.005 | | 0.084 | | 0.011 | | 0.005 | | 0.112 | |
| **two-sided 90% C.I.** | 1.06 ~ 1.07 | | 0.98 ~ 1.15 | | 1.00 ~ 1.02 | | 1.00 ~ 1.01 | | 0.84 ~ 1.07 | |

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| ( 0.8 ~1.25) | Substantial Equivalence | Substantial Equivalence | Substantial Equivalence | Substantial Equivalence | Substantial Equivalence |
| --- | --- | --- | --- | --- | --- |

# *c. Two-sided 90% confidence intervals for cellular composition data at Time 0*

| Time Point 0 hour | WBC | | RBC | | PLT | | PLT Recovery | | Concentration Factor | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate |
| **Data** (n=20) | 8.0 | 8.0 | 0.22 | 0.20 | 728 | 638 | 60.8% | 53.7% | 4.14 | 3.63 |
| | 7.4 | 7.4 | 0.22 | 0.20 | 666 | 654 | 68.0% | 67.3% | 4.63 | 4.54 |
| | 10.2 | 9.6 | 0.34 | 0.32 | 894 | 942 | 67.1% | 71.2% | 4.56 | 4.81 |
| | 9.6 | 9.2 | 0.14 | 0.14 | 1348 | 1254 | 82.3% | 77.1% | 5.59 | 5.20 |
| | 16.2 | 15.4 | 0.82 | 0.72 | 1002 | 992 | 70.5% | 70.3% | 4.79 | 4.75 |
| | 13.2 | 13.0 | 0.46 | 0.44 | 916 | 920 | 69.4% | 70.3% | 4.72 | 4.74 |
| | 8.0 | 7.8 | 0.22 | 0.20 | 782 | 786 | 67.3% | 68.1% | 4.57 | 4.60 |
| | 14.6 | 13.6 | 0.44 | 0.42 | 720 | 684 | 66.6% | 63.7% | 4.53 | 4.30 |
| | 12.0 | 11.2 | 0.58 | 0.54 | 1056 | 1010 | 70.9% | 68.3% | 4.82 | 4.61 |
| | 13.0 | 12.6 | 0.28 | 0.28 | 1204 | 1176 | 72.6% | 71.4% | 4.93 | 4.82 |
| | 13.2 | 13.2 | 0.44 | 0.46 | 976 | 944 | 73.2% | 71.4% | 4.98 | 4.82 |
| | 8.0 | 7.8 | 0.22 | 0.20 | 794 | 758 | 69.1% | 66.4% | 4.70 | 4.49 |
| | 14.6 | 14.0 | 0.44 | 0.42 | 726 | 704 | 66.7% | 65.2% | 4.54 | 4.40 |
| | 10.0 | 9.8 | 0.32 | 0.32 | 970 | 904 | 78.4% | 73.6% | 5.33 | 4.97 |
| | 10.0 | 9.2 | 0.16 | 0.16 | 1398 | 1278 | 77.9% | 71.7% | 5.30 | 4.84 |
| | 15.4 | 14.8 | 0.78 | 0.72 | 1010 | 1002 | 79.4% | 79.4% | 5.40 | 5.36 |
| | 12.8 | 12.0 | 0.32 | 0.26 | 1212 | 1136 | 74.0% | 69.8% | 5.03 | 4.71 |
| | 11.6 | 11.0 | 0.54 | 0.50 | 1012 | 986 | 74.0% | 72.7% | 5.03 | 4.91 |
| | 7.2 | 7.2 | 0.20 | 0.20 | 702 | 722 | 71.2% | 73.8% | 4.84 | 4.98 |
| | 7.8 | 7.4 | 0.20 | 0.20 | 652 | 608 | 57.8% | 54.3% | 3.93 | 3.66 |
| **Mean** | 11.14 | 10.71 | 0.37 | 0.35 | 938.4 | 904.9 | 70.9% | 69.0% | 4.82 | 4.66 |
| **Ratio** | 1.038 | | 1.058 | | 1.037 | | 1.029 | | 1.037 | |
| **S.D.** | 0.027 | | 0.063 | | 0.044 | | 0.044 | | 0.044 | |
| **90% C.I.** | 0.010 | | 0.023 | | 0.016 | | 0.016 | | 0.016 | |
| **two-sided 90% C.I.** ( 0.8 ~1.25) | 1.028 ~ 1.048 | | 1.035 ~ 1.082 | | 1.020 ~ 1.053 | | 1.013 ~ 1.045 | | 1.020 ~ 1.053 | |
| | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | |

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# *d. Two-sided 90% confidence intervals for cellular composition data at Time Point 4 hours.*

| Time Point 4 hours | WBC | | RBC | | PLT | | PLT Recovery | | Concentration Factor | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate | Subject | Predicate |
| **Data** (n=20) | 7.8 | 8.2 | 0.20 | 0.22 | 706 | 728 | 59.0% | 61.3% | 4.01 | 4.14 |
| | 7.6 | 7.4 | 0.22 | 0.20 | 672 | 708 | 68.6% | 72.8% | 4.67 | 4.92 |
| | 9.8 | 9.6 | 0.32 | 0.32 | 908 | 874 | 68.1% | 66.1% | 4.63 | 4.46 |
| | 9.8 | 9.6 | 0.14 | 0.14 | 1318 | 1248 | 80.4% | 76.7% | 5.47 | 5.18 |
| | 15.6 | 15.0 | 0.80 | 0.74 | 1054 | 1018 | 74.2% | 72.2% | 5.04 | 4.87 |
| | 13.2 | 12.8 | 0.44 | 0.44 | 960 | 932 | 72.8% | 71.2% | 4.95 | 4.80 |
| | 8.0 | 7.8 | 0.22 | 0.20 | 798 | 784 | 68.6% | 67.9% | 4.67 | 4.58 |
| | 14.2 | 14.0 | 0.42 | 0.42 | 716 | 690 | 66.2% | 64.3% | 4.50 | 4.34 |
| | 11.4 | 11.4 | 0.56 | 0.56 | 984 | 976 | 66.1% | 66.0% | 4.49 | 4.46 |
| | 13.0 | 12.4 | 0.32 | 0.28 | 1168 | 1106 | 70.4% | 67.2% | 4.79 | 4.53 |
| | 13.6 | 13.2 | 0.48 | 0.44 | 956 | 944 | 71.7% | 71.4% | 4.88 | 4.82 |
| | 7.8 | 7.8 | 0.22 | 0.22 | 794 | 744 | 69.1% | 65.2% | 4.70 | 4.40 |
| | 14.2 | 13.6 | 0.44 | 0.44 | 670 | 720 | 61.6% | 66.7% | 4.19 | 4.50 |
| | 10.2 | 9.8 | 0.34 | 0.28 | 966 | 942 | 78.1% | 76.7% | 5.31 | 5.18 |
| | 9.8 | 9.2 | 0.16 | 0.16 | 1322 | 1264 | 73.6% | 70.9% | 5.01 | 4.79 |
| | 15.6 | 14.6 | 0.82 | 0.74 | 1028 | 956 | 80.8% | 75.7% | 5.50 | 5.11 |
| | 12.6 | 12.8 | 0.28 | 0.34 | 1198 | 1162 | 73.1% | 71.4% | 4.97 | 4.82 |
| | 11.2 | 11.2 | 0.56 | 0.54 | 1018 | 958 | 74.5% | 70.6% | 5.06 | 4.77 |
| | 7.4 | 7.0 | 0.20 | 0.20 | 722 | 692 | 73.2% | 70.7% | 4.98 | 4.77 |
| | 7.8 | 7.6 | 0.22 | 0.20 | 654 | 608 | 57.9% | 54.3% | 3.94 | 3.66 |
| **Mean** | 11.03 | 10.75 | 0.37 | 0.35 | 930.6 | 902.7 | 70.4% | 69.0% | 4.79 | 4.65 |
| **Ratio** | 1.025 | | 1.035 | | 1.028 | | 1.021 | | 1.028 | |
| **S.D.** | 0.028 | | 0.085 | | 0.039 | | 0.039 | | 0.039 | |
| **90% C.I.** | 0.010 | | 0.031 | | 0.014 | | 0.014 | | 0.014 | |
| **two-sided 90% C.I.** (0.8 - 1.25) | 1.014 ~ 1.035 | | 1.004 ~ 1.067 | | 1.014 ~ 1.043 | | 1.006 ~ 1.035 | | 1.014 ~ 1.043 | |
| | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | | Substantial Equivalence | |

We evaluated the substantial equivalence of two devices using the method of two-sided 90% confidence intervals. If two-sided 90% confidence intervals for the ratio of subject device parameter to predicate device parameter is located between 0.80 and 1.25, subject device can be determined as substantial equivalence.

In conclusion, the output from the subject device demonstrated that its cellular composition and functional characteristics is substantially equivalent to the output from the predicate device.

### Biocompatibility testing

The biocompatibility testing has been performed on the sterilized finished form of Dr.PRP according to ISO 10993-1. The platelet-rich plasma (PRP) prepared by the Dr.PRP is intended to be mixed with autograft and/or allograft bone prior to application to a bony defect and therefore the Dr.PRP is categorized as external communicating device which indirectly contacts blood with limited exposure

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(contact of < 24 hrs). All biocompatibility tests have been carried out at Korea Testing Laboratory (KTL, Wonju, Korea) in good laboratory practice (GLP) conditions.

In addition, the bacterial endotoxin testing was performed using the methods described in ANSI/AAMI ST72.

The following tests were included.

- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity (acute)
- Pyrogenicity
- Material-mediated
- Hemolysis
- Pyrogenicity
- Endotoxin-mediated

The Dr.PRP has undergone biocompatibility tests in accordance with ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” and bacterial endotoxin tests in accordance with ANSI/AAMI ST72 “Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing.” The above-mentioned results show the device to be biocompatible and the product to be non-pyrogenic.

### Sterilization validation

The sterilization validation of Dr.PRP was carried out according to the protocol relating to the requirements described in (b) (4)


### Shelf-life validation

It is evaluated that there will be no influence to the quality performance of the packaging even by setting up shelf-life up to 3 year as the result of confirmation of physical and chemical stability and effectiveness through accelerated aging test and real time stability study data of samples irradiated kGy for evaluation of packaging materials according to related standards of ASTM and ISO.

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- Storage conditions: temperature 35.6°F(2°C) - 86°F(30°C)
- Shelf-life: 3 years

# Summary

Based on the performance data as documented in the pivotal performance testing, the Dr.PRP was found to have a safety and effectiveness profile that is similar to the predicate device.

# VIII. CONCLUSIONS

The characteristics and intended use of the Dr.PRP is similar to predicate device, and the predicate device and Dr.PRP are identical in that they are disposable (supplied after being sterilization) device. In addition, performance data was checked to confirm substantial equivalence, and the safety of the equipment was demonstrated.