(44 days)
Not Found
No
The device description and performance studies focus on mechanical components and sterilization, with no mention of AI or ML.
No
The device is described as autoclavable suction jars and lids used for the collection of aspirated fat, which may then be reinjected. Its function is to collect and transfer fat, not to treat a disease or condition directly.
No
The device is used for the collection and transfer of aspirated fat for aesthetic body contouring; it does not diagnose any condition.
No
The device description explicitly details physical components such as suction jars, lids, tubing, and cannulas, and the performance studies focus on nonclinical tests related to these physical components (biocompatibility, leakage, sterilization, etc.). There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of aspirated fat for aesthetic body contouring and potential reinjection. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
- Device Description: The device is described as suction jars and lids used in conjunction with vacuum systems, tubing, and cannulas. These are tools for collecting biological material during a procedure, not for analyzing a sample to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for collection during a surgical procedure.
N/A
Intended Use / Indications for Use
The Millennium Medical Technologies, Inc. Autoclavable Suction Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
The Millennium Medical Technologies line of Fat Collection and Transfer Devices consist of the following:
- Autoclavable Suction Jars and lids with Luer Lock extension and extraction tub - 250, 500, 1,000, 2,000 and 3,000 ml
- Suction Jar without Luer Lock extension 1,500 and 2,500 ml
- Sterile 1,500 and 2,500 ml Lids with Conical patient connection 6-10 and overflow protection
The Millennium Medical Technologies Collection Jars are Suction Canisters molded from medical grade polycarbonate. The 250, 500, 1,000, 2,000 and 3,000 ml canisters have a stainless steel luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500 and 2.500 ml canisters are designed to interface with the Lid with Liner and do not have a fitting at the base of the canister. All of the Collection Jars are provided non-sterile and are autoclavable.
The Millennium Medical Technologies Small and Large Lids are molded from medical grade polypropylene and have various ports, medical grade silicone tubing and a liner to contain all waste. The Large Lid has a 6-10 tapered cone for the 2,500 ml canister and the Small Lid has a 6-10 tapered cone for the 1,500 ml canister. The Lids with Liner are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or surgery center
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)
Nonclinical tests:
- Biocompatibility tests: ISO MEM Elution Using L-329 Mouse Fibroblast Cells, ISO Intracutaneous Irritation Test, ISO Acute Systemic Injection Test, ISO Guinea Pig Maximization Sensitization Test.
- Leakage and compatibility of Collection Jars with Lids and Liners.
- Accuracy of the MMT Fat Collection and Transfer Devices compared to the comparative predicate device.
- Gamma Irradiation Sterilization Validation per ISO 11137-1:2006;Amd. 1, 2013 for sterile product.
- Cleaning Validation per AAMI O TIR30:2011 Guidance document for autoclavable product.
- Sterilization Validation for a gravity autoclave per TIR N0. 12-2004 and ISO 17665-1:2006/(R) 2013 for autoclavable product.
Key results: Performance testing has demonstrated that the products' efficacy and effectiveness is substantially equivalent to the predicate device.
Clinical tests: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is centered on the page.
March 31, 2017
Millennium Medical Technologies, Inc. Mr. Jim Barley Director of Regulatory Affairs 6352 Corte Del Abeto Suite A Carlsbad, California 92011
Re: K170449
Trade/Device Name: Autoclavable Suction Jar With Luer Lock Extension - 250, 500, 1,000, 2,000 And 3,000 Ml, Autoclavable Suction Jar Without Luer Lock Extension - 1,500 And 2,500 Ml, Sterile 1,500 And 2,500 Lids With Conical Patient Connection 6-10 And Overflow Protection Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: January 27, 2017 Received: February 15, 2017
Dear Mr. Barley:
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. 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.
Image /page/0/Picture/10 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, stacked on top of each other.
1
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170449
Device Name
· MMT Autoclavable Suction Jar with Luer Lock extension- 250, 500, 1.000, 2.000 and 3.000 ml.
· MMT Autoclavable Suction Jar - 1.500 and 2.500 ml
· MMT Sterile and non sterile 1,500 Lids with Conical patient connection 6-10 and overflow protection
Indications for Use (Describe)
The Millennium Medical Technologies, Inc. Autoclavable Suction Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
FAT COLLECTION AND TRANSFER DEVICES
510(k) Summary (As required by 21 CFR 807.92(a))
Applicant and Correspondent
| Name: | Millennium Medical Technologies, Inc. | |
|---|---|---|
| Address: | 6352 Corte Del Abeto, Ste. A | |
| Carlsbad, CA 92011 | ||
| Contact: | Greg Miles | |
| Phone Numbers: | (949) 215-8560 (Voice) | |
| Date of Preparation: | March 10, 2017 | |
| Manufacturer | Millennium Medical Technologies, Inc. | |
| 6352 Corte Del Abeto, Ste. A | ||
| Carlsbad, CA 92011 | ||
| Registration#: | 2032809 | |
| Name of Device | Trade/Proprietary/Model Name: |
- MMT line of Collection Jars & Transfer Devices
- Autoclavable Suction Jars and Lids with Luer Lock extension and extraction tube - 250, 500, 1,000, 2,000 and 3,000 ml
- Suction Jar without Luer Lock extension - 1,500 and 2,500 ml
- Sterile 1,500 ml and 2,500 ml Lids with Liner and Conical patient connection 6-10 and overflow protection | |
| Common Name: | Fat Collection and Transfer Devices | |
| Classification Name: | Suction Lipoplasty System | |
| Classification Regulation: | 878.5040 | |
| Panel: | General and Plastic Surgery | |
| Product Code: | MUU | |
| Recognized Performance Std: | None | |
Device to Which New Device is Substantially Equivalent
| Device Name: | Tissu-Trans Filtron |
|---|---|
| Manufacturer: | Shippert Medical Technologies, Inc. |
4
FAT COLLECTION AND TRANSFER DEVICES K092482
Reference:
510(k) SUMMARY (Continued)
Device Description
The Millennium Medical Technologies line of Fat Collection and Transfer Devices consist of the following:
-
- Autoclavable Suction Jars and lids with Luer Lock extension and extraction tub - 250, 500, 1,000, 2,000 and 3,000 ml
-
- Suction Jar without Luer Lock extension 1,500 and 2,500 ml
-
- Sterile 1,500 and 2,500 ml Lids with Conical patient connection 6-10 and overflow protection
The Millennium Medical Technologies Collection Jars are Suction Canisters molded from medical grade polycarbonate. The 250, 500, 1,000, 2,000 and 3,000 ml canisters have a stainless steel luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500 and 2.500 ml canisters are designed to interface with the Lid with Liner and do not have a fitting at the base of the canister. All of the Collection Jars are provided non-sterile and are autoclavable.
The Millennium Medical Technologies Small and Large Lids are molded from medical grade polypropylene and have various ports, medical grade silicone tubing and a liner to contain all waste. The Large Lid has a 6-10 tapered cone for the 2,500 ml canister and the Small Lid has a 6-10 tapered cone for the 1,500 ml canister. The Lids with Liner are provided sterile.
Statement of Intended Use
The Millennium Medical Technologies, Inc. Collection Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be re-injected via a cleared injection apparatus.
Summary of Technological Characteristics
The Intended Use statement of the MMT Collection Jars and Lids with Liners is identical to that of the predicate. The materials of construction used in the MMT Collection Jars and Lids with Liners are identical to those of the predicate device. Performance testing has demonstrated that the products' efficacy and effectiveness is substantially equivalent to the predicate device.
A comparison of the MMT Collection Jars and Lids with Liners to the predicate device, the Shippert Medical Technologies Collection Jars and Lids with Liners is given in Table 1
5
FAT COLLECTION AND TRANSFER DEVICES
| | Parameter Description | Predicate Device:
SMT Tissu Trans Filtron | Subject Device:
MMT Fat Collection and Transfer System | Comparison of
Subject
Device to
Predicate |
|-------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Technological Characteristics | FDA Predicate # | K092482 | K170449 | N/A |
| | Product Code | MUU | MUU | Same |
| | Clearance Date | 12/4/2009 | TBD | N/A |
| | Indication for Use | The Tissu Trans Filtron is
intended to be used with house
vacuum and/or cleared pumps,
tubing and cannulas, for the
collection of aspirated fat, for
aesthetic body contouring. If
the fat is untreated, it may be
re-injected via a cleared
injection apparatus. | The Millennium Medical Technologies,
Inc.(MMT) Fat Collection and Transfer
Devices are intended to be used with house
vacuum and/or cleared pumps, tubing and
cannulas, for the collection of aspirated fat,
for aesthetic body contouring. If the fat is
untreated, it may be re-injected via a
cleared injection apparatus. | Same |
| | Description | The Tissu Trans Fltron is
provided in a sterile, two piece
packaged assembly. The Tissu
Trans Filtron. The Tissu Trans
Filtron is a single-use, sterile,
disposable device designed to
utilize an FDA cleared house
vacuum to create suction within
the physician supplied hollow
liposuction and remove
subcutaneous fatty tissue from
the patient and transport the
autologous tissue into the
collection canister. | The Millennium Medical Technologies
Collection Jars are suction canisters
molded from medical grade polycarbonate.
The 250, 500, 1,000, 2,000 and 3,000 ml
canisters are provided non-sterile and are
autoclavable. Each Collection Jar has a
stainless steel luer fitting at its base to
facilitate the transfer of untreated fat back
into the patient using a cleared injection
apparatus.
The 1,500 and 2,500 ml collection jars are
also molded from medical grade
polycarbonate and are used with the MMT
Lids with Liners. The 1,500 and 2,500 ml
collection jars are autoclavable.
The Millennium Medical Technologies
Small and Large Lids are molded from
medical grade polypropylene and have
various ports, medical grade silicone
tubing and a liner to contain all waste.
The Large Lid has a 6-10 tapered cone
for the 2,500 ml canister and the Small
Lid has a 6-10 tapered cone for the
1,500 ml canister. The Lids are
provided sterile. | Similar
and SE |
| | Parameter Description | Predicate Device:
SMT Tissu Trans Filtron | Subject Device:
MMT Fat Collection and Transfer System | Comparison
on of
Subject
Device to
Predicate |
| Specification | Autoclavable
Collection Jars for
Lids w/Liner | 500, 1,000 and 2,000 Liners | 1,500 and 2,500 Liners | SE |
| | Autoclavable
Collection Jars | 250, 500, 1,000, 2,000 and
3,000 ml | 250, 500, 1,000, 2,000 and 3,000 ml | Same |
| | Collection Jar
Lids | Large and Small Lids | Large and Small Lids | Same |
| Style | Collection Jar rim
diameter | 2 sizes | 2 sizes | Same |
| | Design | Jar with handle | Jar with handle | Same |
| | Scale units | mL | mL | Same |
| | Port at base of
Collection Jar | No | Yes | Different |
| Other
Features | Method to
separate waste
from fat | Vacuum fat through filter | Gravity | Different |
| | Waste Jar
required | Yes | No | Different |
| How
Supplied | Non-Sterile | Collection Jars | Collection Jars | Same |
| | Sterile | Collection Jar with Lid and
Filter | Lid with Bag Liner | Different |
6
FAT COLLECTION AND TRANSFER DEVICES
Brief description of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.
- The following biocompatibility tests were conducted on the MMT Fat Collection and Transfer Devices:
- o ISO MEM Elution Using L-329 Mouse Fibroblast Cells
- o ISO Intracutaneous Irritation Test
- ISO Acute Systemic Injection Test o
- o ISO Guinea Pig Maximization Sensitization Test
7
FAT COLLECTION AND TRANSFER DEVICES
- · The MMT Fat Collection and Transfer Devices were tested for leakage and compatibility of Collection Jars with Lids and Liners. In addition, the accuracy of the MMT) Fat Collection and Transfer Devices was compared to the comparative predicate device.
- · For the product supplied sterile, Millennium Medical conducted a Gamma Irradiation Sterilization Validation per the requirements of ISO 11137-1:2006;Amd. 1, 2013.
- For the autoclavable product;
- A Cleaning Validation was performed in accordance with the AAMI O TIR30:2011 Guidance document. The Cleaning Validation was conducted to ensure that once the device has been used, it can be properly cleaned for resterilization.
- o A Sterilization Validation for a gravity autoclave was conducted per the requirements of TIR N0. 12-2004 and ISO 17665-1:2006/(R) 2013. The product was prepared with a resistant organism at a population of 1.0 X 106 colony forming units (CFU), subjected to a gravity autoclave cycle at one half the intended time for resterilization, then sterility tested. In addition, the 10 minute default autoclave drying cycle was qualified.
Brief discussion of clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.
Not applicable.
Conclusion drawn for the nonclinical and clinical tests
The MMT Fat Collection and Transfer Devices have the same intended use and technological characteristics as the predicate device, Shippert Medical Technologies. The materials of construction used in the MMT) Fat Collection and Transfer Devices are substantially equivalent to those of the predicate device. Performance testing has demonstrated the product's efficacy. The MMT) Fat Collection and Transfer Devices have been demonstrated to be substantially equivalent to the predicate device.