PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM

K131630 · Puritan Medical Products, LLC · LIO · Oct 21, 2013 · Microbiology

Device Facts

• Record ID: K131630
• Device Name: PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
• Applicant: Puritan Medical Products, LLC
• Product Code: LIO · Microbiology
• Decision Date: Oct 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Intended Use

Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Device Story

System consists of sterile peel pouch containing rayon-tipped swab applicator and polypropylene tube with 4 ml Amies medium (with or without charcoal). Medium is nonnutritive balanced salt solution (inorganic phosphates, NaCl, KCl, CaCl2, MgCl2) with agar for semi-solid texture and sodium thioglycollate for reduced environment. Used by clinicians to collect clinical specimens; swab transports specimen to laboratory. Maintains viability of aerobic, anaerobic, and fastidious bacteria during transport. Benefits patient by ensuring specimen integrity for accurate bacteriological examination and culture.

Clinical Evidence

Bench testing only. Recovery testing performed per CLSI M40-A guidelines using ATCC type cultures and clinically significant microorganisms; no significant differences in recovery compared to predicate. Stability testing confirmed microbial recovery up to 24-month expiry. pH stability verified over 24 months. Cytotoxicity testing performed per ISO Elution Method-1X MEM Extract; no evidence of cytotoxicity detected.

Technological Characteristics

Materials: Rayon-tipped swab, polypropylene tube, bacteriological agar. Medium: Balanced salt solution (inorganic phosphates, NaCl, KCl, CaCl2, MgCl2, sodium thioglycollate). pH 7.3 ± 0.2. Sterilization: Gamma irradiation per ANSI/AAMI/ISO 11137:2006. Form factor: Round bottom tube. Storage: 4-25°C.

Indications for Use

Indicated for the collection and transport of clinical specimens containing aerobic, anaerobic, and fastidious bacteria from patients to the laboratory for bacteriological examination and culture.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• Copan Venturi Transystem Amies Medium Without Charcoal (k972448)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k131630

B. Purpose for Submission:
To make a substantial equivalence determination for the Puritan® Amies Medium Collection and Transport System for the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

C. Measurand:
Not applicable.

D. Type of Test:
Transport culture medium device

E. Applicant:
Puritan® Medical Products LLC

F. Proprietary and Established Names:
Puritan® Amies Medium Collection and Transport System

G. Regulatory Information:
1. Regulation section:
866.2900; Microbiological specimen collection and transport devices
2. Classification:
Class I
3. Product code:
LIO: Device, Specimen Collection
JTW: System, Transport, Aerobic
JTX: Transport Systems, Anaerobic

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4. Panel:

83- Microbiology

H. Intended Use:

1. Intended use(s):

Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

2. Indication(s) for use:

Same as intended use(s).

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

None.

I. Device Description:

Puritan® Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types.

Amies medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycolate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria such as Neisseria gonorrhoeae during the transport to the laboratory. It also contains thioglycolate salt to provide a reduced environment and chloride salts to help maintain osmotic balance and control permeability of bacterial cells.

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Approximate Amies medium without charcoal formulation per liter:

| Sodium chloride | 3.0g |
| --- | --- |
| Disodium phosphate | 1.2g |
| Sodium thioglycolate | 1.0g |
| Monopotassium phosphate | 0.2g |
| Potassium chloride | 0.2g |
| Calcium chloride | 0.1g |
| Magnesium chloride | 0.1g |
| Bacteriological agar | 6.5g |

The Puritan® Amies Medium Collection and Transport System with charcoal has the same formulation as above with the addition of 10g of charcoal.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Copan Venturi Transystem Amies Medium Without Charcoal

2. Predicate 510(k) number(s):

k972448

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Puritan® Amies Medium Collection and Transport System (131630) | Copan Venturi Transystem Amies Medium Without Charcoal (k972448) |
| Intended Use | Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture. | The Copan Venturi Transystem Amies Medium Without Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium Without Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria. |
| Indication for Use | Same as intended use. | Same as intended use. |
| Single-Use Device | Yes | Same |
| Medium Formulation | Sodium chloride Disodium phosphate Sodium thioglycollate Monopotassium phosphate Potassium chloride Calcium chloride Magnesium chloride Bacteriological agar (Amies with charcoal has the same formulation as above with the addition of charcoal.) | Same |
| pH | 7.3 ± 0.2 | Same |
| Storage Temperature | 4-25°C (refrigerated and room temperature) | Same |

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| Container | Plastic round bottom tube | Same |
| --- | --- | --- |
| Product Configuration | Medium in tubes & Plug System including Medium and swab in peel pouch option. | Same |
| Swab Shaft | Plastic | Same |
| Swab Tip | Rayon tipped swab | Same |
| Shelf Life | 24 months | Same |

K. Standard/Guidance Document Referenced (if applicable):

Quality Control of Microbiological Transport Systems; Approved Standard, M40-A, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2003.

L. Test Principle:

Not applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

The performance characteristics of Puritan® Amies Medium with and without charcoal were determined using the Roll Plate Method outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A document using different rayon-tipped swab types designed for throat, urogenital and nasal specimen collection. A variety of aerobic, anaerobic, and fastidious organisms were included in this study. The test organisms comprised of the ten ATCC strains that are recommended in the CLSI M40-A document for determining performance characteristics of swab transport systems. To determine the performance characteristics of the Puritan® Amies Medium with and without charcoal, bacterial viability studies were performed. These studies were conducted in refrigerated (4-8°C) and room temperature (20-25°C) conditions. The swabs from each transport system were inoculated in duplicate with a specified volume of select bacterial concentrations. These swabs were then placed in their respective transport vial and held for 0, 24, and 48 hours; at the designated time intervals the swabs were removed and processed.

Organisms evaluated:

A. Aerobes and Facultative Anaerobes:

1. Pseudomonas aeruginosa ATCC BAA-427
2. Streptococcus pyogenes ATCC 19615
3. Streptococcus pneumoniae ATCC 6305
4. Haemophilus influenzae ATCC 10211

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B. Anaerobes

1. Bacteroides fragilis ATCC 25285
2. Peptostreptococcus anaerobius ATCC 27337
3. Fusobacterium nucleatum ATCC 25586
4. Propionibacterium acnes ATCC 6919
5. Prevotella melaninogenica ATCC 2584

C. Fastidious

1. Neisseria gonorrhoeae ATCC 43069

Acceptance criteria for recovery of bacteria as recommended in the CLSI document M40-A are followed. Manual colony counts were conducted for the Roll-Plate Method at all three time intervals for each swab-organism combination and the average was recorded. Three dilutions were analyzed for each test organism and the dilution yielding zero-time colony counts nearest to 300 CFU was reported. These viability results are acceptable.

The results of the study by Roll-Plate Method are presented in Tables 1-4 below for 3 lots of media each for the media formulations with and without charcoal. The results demonstrate that the Puritan® Amies Medium with and without charcoal were able to maintain the viability of all organisms up to 48 hours at room temperature (20-25°C) and under refrigerated (4-8°C) conditions. Neisseria gonorrhoeae results support acceptable recoveries up to 24 h, as recommended in the CLSI guidance M40-A. There is no CLSI M40-A interpretation for N. gonorrhoeae beyond 24 h of storage using the Roll Plate Method.

Viability performance studies on all of the organisms above also included an assessment of performance evaluation and overgrowth per CLSI M40-A section 7.12.1 – 7.12.5. Overgrowth assessment as defined in CLSI M40-A guideline is greater than one-log₁₀ increase in CFU between zero-time and the holding time point. There was no increase in bacterial count for all organisms tested when the samples were stored at room temperature. The data provided is in conformance with the guidelines in CLSI M40-A at room temperature.

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Table 1. Bacterial recovery results for Puritan Amies Medium without Charcoal using the Roll-Plate Method at room temperature conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-5 | Puritan - 121026 | 148 | 64 | 38 |
| | | Puritan - 121102 | 161 | 83 | 49 |
| | | Puritan - 121217 | 130 | 49 | 25 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 121026 | 280 | 263 | 220 |
| | | Puritan - 121102 | 291 | 286 | 206 |
| | | Puritan - 121217 | 240 | 210 | 200 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 121026 | 207 | 74 | 46 |
| | | Puritan - 121102 | 126 | 63 | 13 |
| | | Puritan - 121217 | 200 | 150 | 62 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 121026 | 152 | 108 | 82 |
| | | Puritan - 121102 | 206 | 105 | 50 |
| | | Puritan - 121217 | 181 | 80 | 54 |
| Bacteroides fragilis ATCC 25285 | Diluted 10-5 | Puritan - 121026 | 285 | 110 | 109 |
| | | Puritan - 121102 | 260 | 188 | 166 |
| | | Puritan - 121217 | 260 | 130 | 130 |
| Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-5 | Puritan - 121026 | 92 | 40 | 24 |
| | | Puritan - 121102 | 86 | 60 | 42 |
| | | Puritan - 121217 | 95 | 71 | 59 |
| Fusobacterium nucleatum ATCC 25586 | Diluted 10-4 | Puritan - 121026 | 159 | 76 | 31 |
| | | Puritan - 121102 | 150 | 60 | 45 |
| | | Puritan - 121217 | 145 | 110 | 106 |
| Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 121026 | 116 | 95 | 61 |
| | | Puritan - 121102 | 123 | 82 | 53 |
| | | Puritan - 121217 | 110 | 70 | 37 |
| Prevotella melaninogenica ATCC 25845 | Diluted 10-4 | Puritan - 121026 | 112 | 44 | 29 |
| | | Puritan - 121102 | 131 | 89 | 38 |
| | | Puritan - 121217 | 115 | 62 | 26 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-5 | Puritan - 121026 | 160 | 60 | |
| | | Puritan - 121102 | 216 | 69 | |
| | | Puritan - 121217 | 132 | 101 | |

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Table 2. Bacterial recovery results for Puritan Amies Medium with Charcoal using the Roll-Plate Method at room temperature conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 121203 | 124 | 44 | 27 |
| | | Puritan - 121217 | 110 | 26 | 14 |
| | | Puritan - 130111 | 132 | 112 | 76 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 121203 | 248 | 167 | 126 |
| | | Puritan - 121217 | 290 | 276 | 250 |
| | | Puritan - 130111 | 270 | 123 | 90 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 121203 | 224 | 100 | 21 |
| | | Puritan - 121217 | 111 | 76 | 40 |
| | | Puritan - 130111 | 128 | 52 | 42 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 121203 | 144 | 74 | 24 |
| | | Puritan - 121217 | 277 | 178 | 75 |
| | | Puritan - 130111 | 215 | 88 | 60 |
| Bacteroides fragilis ATCC 25285 | Diluted 10-5 | Puritan - 121203 | 198 | 123 | 86 |
| | | Puritan - 121217 | 138 | 125 | 38 |
| | | Puritan - 130111 | 195 | 135 | 64 |
| Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-5 | Puritan - 121203 | 235 | 100 | 82 |
| | | Puritan - 121217 | 206 | 41 | 20 |
| | | Puritan - 130111 | 190 | 28 | 21 |
| Fusobacterium nucleatum ATCC 25586 | Diluted 10-4 | Puritan - 121203 | 240 | 159 | 90 |
| | | Puritan - 121217 | 295 | 162 | 36 |
| | | Puritan - 130111 | 245 | 214 | 46 |
| Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 121203 | 70 | 50 | 45 |
| | | Puritan - 121217 | 70 | 27 | 21 |
| | | Puritan - 130111 | 80 | 23 | 18 |
| Prevotella melaninogenica ATCC 25845 | Diluted 10-4 | Puritan - 121203 | 144 | 88 | 39 |
| | | Puritan - 121217 | 170 | 111 | 68 |
| | | Puritan - 130111 | 129 | 94 | 55 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-5 | Puritan - 121203 | 82 | 64 | |
| | | Puritan - 121217 | 107 | 73 | |
| | | Puritan - 130111 | 67 | 26 | |

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Table 3. Bacterial recovery results for Puritan Amies Medium without Charcoal using the Roll-Plate Method at refrigerated (4-8°C) conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-5 | Puritan - 121026 | 230 | 178 | 131 |
| | | Puritan - 121102 | 286 | 219 | 195 |
| | | Puritan - 121217 | 185 | 122 | 89 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 121026 | 233 | 210 | 206 |
| | | Puritan - 121102 | 267 | 235 | 229 |
| | | Puritan - 121217 | 251 | 234 | 219 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 121026 | 239 | 153 | 113 |
| | | Puritan - 121102 | 218 | 169 | 138 |
| | | Puritan - 121217 | 189 | 151 | 129 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 121026 | 176 | 130 | 115 |
| | | Puritan - 121102 | 194 | 146 | 121 |
| | | Puritan - 121217 | 169 | 132 | 104 |
| Bacteroides fragilis ATCC 25285 | Diluted 10-5 | Puritan - 121026 | 265 | 224 | 179 |
| | | Puritan - 121102 | 274 | 246 | 211 |
| | | Puritan - 121217 | 211 | 192 | 157 |
| Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-5 | Puritan - 121026 | 113 | 78 | 61 |
| | | Puritan - 121102 | 80 | 63 | 55 |
| | | Puritan - 121217 | 91 | 75 | 66 |
| Fusobacterium nucleatum ATCC 25586 | Diluted 10-4 | Puritan - 121026 | 184 | 159 | 120 |
| | | Puritan - 121102 | 153 | 118 | 94 |
| | | Puritan - 121217 | 169 | 130 | 119 |
| Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 121026 | 135 | 128 | 115 |
| | | Puritan - 121102 | 112 | 87 | 65 |
| | | Puritan - 121217 | 129 | 113 | 91 |
| Prevotella melaninogenica ATCC 25845 | Diluted 10-4 | Puritan - 121026 | 144 | 91 | 57 |
| | | Puritan - 121102 | 157 | 132 | 88 |
| | | Puritan - 121217 | 125 | 84 | 68 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-5 | Puritan - 121026 | 168 | 99 | |
| | | Puritan - 121102 | 179 | 112 | |
| | | Puritan - 121217 | 174 | 128 | |

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Table 4. Bacterial recovery results for Puritan Amies Medium with Charcoal using the Roll-Plate Method at refrigerated (4-8°C) conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-5 | Puritan - 121203 | 140 | 131 | 110 |
| | | Puritan - 121217 | 133 | 117 | 86 |
| | | Puritan - 130111 | 158 | 120 | 109 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 121203 | 225 | 196 | 165 |
| | | Puritan - 121217 | 238 | 204 | 185 |
| | | Puritan - 130111 | 244 | 212 | 189 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 121203 | 255 | 143 | 91 |
| | | Puritan - 121217 | 216 | 168 | 139 |
| | | Puritan - 130111 | 228 | 179 | 158 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 121203 | 249 | 216 | 178 |
| | | Puritan - 121217 | 167 | 125 | 88 |
| | | Puritan - 130111 | 209 | 162 | 122 |
| Bacteroides fragilis ATCC 25285 | Diluted 10-5 | Puritan - 121203 | 174 | 142 | 118 |
| | | Puritan - 121217 | 151 | 116 | 94 |
| | | Puritan - 130111 | 183 | 161 | 133 |
| Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-5 | Puritan - 121203 | 246 | 141 | 100 |
| | | Puritan - 121217 | 198 | 129 | 64 |
| | | Puritan - 130111 | 224 | 118 | 76 |
| Fusobacterium nucleatum ATCC 25586 | Diluted 10-4 | Puritan - 121203 | 213 | 131 | 82 |
| | | Puritan - 121217 | 281 | 174 | 115 |
| | | Puritan - 130111 | 276 | 162 | 126 |
| Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 121203 | 113 | 94 | 87 |
| | | Puritan - 121217 | 95 | 85 | 61 |
| | | Puritan - 130111 | 86 | 71 | 47 |
| Prevotella melaninogenica ATCC 25845 | Diluted 10-4 | Puritan - 121203 | 159 | 114 | 86 |
| | | Puritan - 121217 | 189 | 138 | 112 |
| | | Puritan - 130111 | 134 | 103 | 72 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-5 | Puritan - 121203 | 126 | 111 | |
| | | Puritan - 121217 | 115 | 89 | |
| | | Puritan - 130111 | 139 | 123 | |

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a. Precision/Reproducibility:
Not applicable.

b. Linearity/assay reportable range:
Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Accelerated shelf life stability test were performed successfully on 3 lots of product demonstrating stability for up to 24 months at room temperature.

pH Stability: The pH of the test device was measured at predetermined time intervals up to 24 month after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Amies Medium. All samples tested were found to maintain pH within the specified range.

Cytotoxicity: Cytotoxicity test was conducted to evaluate glue, shaft and the rayon tipped swabs for potential cytotoxicity effect following ISO Elution Method-1X MEM Extract. No evidence of cytotoxicity was detected.

Sterilization: Puritan Amies Medium are sterilized by gamma irradiation and validated following ANSI/ AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines.

d. Detection Limit:
Not applicable.

e. Analytical Specificity:
Not applicable.

f. Assay Cut-off:
Not applicable.

2. Comparison studies:
a. Method comparison with predicate device:

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Method comparison is not applicable for a bacterial transport medium. The device itself does not provide a result that can be used in making a clinical decision.

Bench testing studies were done to determine the ability of the Puritan® Amies Medium Collection and Transport System to maintain viability of different strains of aerobes, anaerobes and fastidious bacteria. It showed recovery of bacteria within the acceptance criteria recommended in the CLSI M40-A guidelines like the predicate device. (See above under Performance Characteristics).

b. Matrix comparison:

Not applicable.

3. Clinical Studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

Not applicable.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The information submitted in this premarket notification is complete and supports a substantial equivalence decision.

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