(386 days)
No
The summary describes a disposable system for harvesting and transferring adipose tissue with mechanical components (cannulae, filters, etc.). There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
The device is described as a sterile medical device for the closed-loop processing and transfer of lipoaspirate tissue, not a device directly applying treatment or therapy. It facilitates a medical procedure, but is not therapeutic itself.
No
The device is described as a system for harvesting and transferring autologous adipose tissue, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly outlines physical components such as cannulae, filters, resizer, luer adapters, and syringe caps, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue." This describes a surgical procedure involving the body, not a test performed on samples outside the body to diagnose a condition.
- Device Description: The description details components like cannulae, filters, and luer adapters, which are consistent with surgical tools for tissue manipulation, not diagnostic reagents or instruments.
- Lack of Diagnostic Language: There is no mention of analyzing samples, detecting biomarkers, diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
- Clinical Testing Not Required: The summary of performance studies states that "Clinical testing was not required." This is typical for surgical devices but not for IVDs, which often require clinical studies to demonstrate diagnostic accuracy.
In summary, the device is designed for a surgical procedure involving the harvesting and transfer of tissue within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.
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
Not Found
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 testing included:
- Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen
- Sterilization validation
- Packaging validation
- Nucleated cell viability
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.
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.
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March 16, 2022
Millennium Medical Technologies Inc (DBA Cellmyx) % Jacqueline Hauge Regulatory Consultant Cellmvx 37743 175th Avenue Avon, Minnesota 56310
Re: K210528
Trade/Device Name: IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit IntelliFat Body On Demand (BOD) Kit Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: January 28, 2022 Received: January 31, 2022
Dear Jacqueline Hauge:
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.
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 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 (QS) 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 medical devices and radiation-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.
for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210528
Device Name intelliFat™ Disposable Adipose Tissue Harvesting and Transfer Kit intelliFat™ BOD Kit
Indications for Use (Describe)
The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
| 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) |
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3
Date Prepared:
l.
Submitter
March 15, 2022
Name and Address: Cellmyx 6352 Corte Del Abeto Suite A Carlsbad, CA 92011 Primary Contact: Jacqueline A. Hauge Regulatory Consultant Minneapolis, MN Phone: 763-269-2069 Email: jacqueline.hauge@gmail.com Secondary Contact: Michelle Nguyen Quality Assurance and Regulatory Manager, Cellmyx 6352 Corte de Abeto, Suite A Carlsbad, CA 92011 Phone: (949) 215-8560 Email: michelle@cellmyx.com II. Device Information FDA Product Code: MUU FDA Regulation Number: 21 CFR 878.5040 FDA Classification Name: System, Suction, Lipoplasty Classification Panel: General and Plastic Surgery Common Name: Lipoplasty System
FDA Classification: Class II
intelliFat™ Disposable Adipose Tissue Harvesting and Transfer Kit Device Name:
intelliFat™ Body On-Demand (BOD) Kit
| Predicate | 510(k) Number | Trade Name | Submitter |
|---|---|---|---|
| Primary | K161636 | Lipogems System | Lipogems International SpA |
| Reference | K162932 | Ranfac Fat Aspiration Cannula | Ranfac Corp. |
| Reference | K113255 | Puregraft 850/PURE System | Cytori Therapeutics, Inc. |
lll. Predicate Information
4
IV. Device Description
The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.
V. Indication for Use
The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
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Image /page/5/Picture/1 description: The image shows the logo for Cellmyx. The logo consists of a cluster of three yellow hexagons on the left, followed by the word "Cellmyx" in a simple, sans-serif font. The word is in black, and the "x" has a unique design where the two lines do not intersect in the middle.
VI. Comparison of Technological Characteristics
| Technological
| Characteristics | Predicate Device | Reference Devices | Subject Device | |
|---|---|---|---|---|
| Lipogems System | Ranfac Fat Aspiration Cannula | Puregraft 850/PURE | ||
| System | IntelliFat™ Kits | |||
| Regulatory Information | ||||
| 510(k) Number | K161636 | K162932 | K113255 | This submission |
| Device Name | Lipogems System | Ranfac Fat Aspiration Cannula | Puregraft 850/PURE System | intelliFat Disposable Adipose |
| Tissue Harvesting and | ||||
| Transfer Kit, | ||||
| intelliFat BOD Kit | ||||
| Manufacturer | Lipogems International SpA | Ranfac Corp. | Cytori Therapeutics, Inc. | Cellmyx |
| Common Name | Lipoplasty System | Ranfac Fat Aspiration Cannula | Puregraft 850/PURE System | Lipoplasty System |
| Regulation Number | 21 CFR 878.5040 | 21 CFR 878.5040 | 21 CFR 878.5040 | 21 CFR 878.5040 |
| Device Class | Class II | Class II | Class II | Class II |
| Product Code | MUU | MUU | MUU | MUU |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery |
| Intended Use | ||||
| Indications for Use | ||||
| Statement | The Lipogems System is a | |||
| sterile medical device | ||||
| intended for the closed- | ||||
| loop processing of | ||||
| lipoaspirate tissue in | ||||
| medical procedures | ||||
| involving the harvesting, | ||||
| concentrating, and | ||||
| transferring of autologous | ||||
| adipose tissue harvested | ||||
| with a legally marketed | ||||
| lipoplasty system. The | ||||
| device is intended for use in | The Ranfac Fat Aspiration | |||
| Cannula are intended for use in | ||||
| aesthetic body contouring. If | ||||
| harvested fat is to be re- | ||||
| implanted, the harvested fat is | ||||
| only to be used without any | ||||
| additional manipulation. | The Puregraft 850/PURE | |||
| System is indicated for use | ||||
| in the harvesting, filtering | ||||
| and transferring of | ||||
| autologous fat tissue for | ||||
| reinjecting back into the | ||||
| same patient for aesthetic | ||||
| body contouring. | The intelliFat Disposable | |||
| Adipose Tissue Harvesting | ||||
| and Transfer or BOD Kit is a | ||||
| sterile medical device | ||||
| intended for the closed-loop | ||||
| processing of lipoaspirate | ||||
| tissue in medical procedures | ||||
| involving the harvesting, | ||||
| concentrating, and | ||||
| transferring of autologous | ||||
| adipose tissue harvested with | ||||
| a legally marketed lipoplasty | ||||
| system. The device is | ||||
| intended for use in the | ||||
| Technological | ||||
| Characteristics | Predicate Device | |||
| Lipogems System | Reference Devices | Subject Device | ||
| IntelliFat™ Kits | ||||
| specialties when the | ||||
| transfer of harvested | ||||
| adipose tissue is desired: | ||||
| orthopedic surgery, | ||||
| arthroscopic surgery, | ||||
| neurosurgery, | ||||
| gastrointestinal and | ||||
| affiliated organ surgery, | ||||
| urological surgery, general | ||||
| surgery, gynecological | ||||
| surgery, thoracic surgery, | ||||
| laparoscopic surgery, and | ||||
| plastic and reconstructive | ||||
| surgery when aesthetic | ||||
| body contouring is desired. | ||||
| Only legally marketed | ||||
| accessory items, such as | ||||
| syringes, should be used | ||||
| with the system. If | ||||
| harvested fat is to be | ||||
| transferred, the harvested | ||||
| fat is only to be used | ||||
| without any additional | ||||
| manipulation. | Ranfac Fat Aspiration Cannula | Puregraft 850/PURE | ||
| System | following surgical specialties | |||
| when the transfer of | ||||
| harvested adipose tissue is | ||||
| desired: orthopedic surgery, | ||||
| arthroscopic surgery, | ||||
| neurosurgery, | ||||
| gastrointestinal and affiliated | ||||
| organ surgery, urological | ||||
| surgery, general surgery, | ||||
| gynecological surgery, | ||||
| thoracic surgery, laparoscopic | ||||
| surgery, and plastic and | ||||
| reconstructive surgery when | ||||
| aesthetic body contouring is | ||||
| desired. Only legally | ||||
| marketed accessory items, | ||||
| such as syringes, should be | ||||
| used with the system. If | ||||
| harvested fat is to be | ||||
| transferred, the harvested fat | ||||
| is only to be used without any | ||||
| additional manipulation. | ||||
| Technological Characteristics | - | - | - | - |
| System | Closed loop | - | Closed loop | Closed loop |
| Construction | Preassembled | - | - | Assembly by user |
| Use and Sterility | Single-use, sterile | Single-use, sterile | Single-use, sterile | Single-use, sterile |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Gamma irradiation | Gamma Radiation |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible |
| Technological | ||||
| Characteristics | Predicate Device | |||
| Lipogems System | Reference Devices | |||
| Ranfac Fat Aspiration Cannula | Reference Devices | |||
| Puregraft 850/PURE | ||||
| System | Subject Device | |||
| IntelliFat™ Kits | ||||
| Mechanical Operation | Manual shaking of stainless- | |||
| steel spheres through | ||||
| filtered chamber | - | Manually operated system | ||
| that receive adipose tissue, | ||||
| filter the adipose tissue, | ||||
| and temporarily hold the | ||||
| adipose tissue until it is | ||||
| removed or placed into a | ||||
| syringe that delivers / re- | ||||
| injects the adipose tissue | ||||
| back into the same patient | ||||
| during the same surgical | ||||
| procedure | Manual transfer back and | |||
| forth through filtered syringe | ||||
| Source of Energy | None required | None required | None required | None required |
| Tissue Washing Media | Physiological saline | - | - | Physiological saline |
| Harvesting Cannula Ga. | ||||
| Size | 13Ga. | 11Ga., 13Ga. & 14Ga. | - | 12Ga. |
| Harvesting Cannula | ||||
| Length | 19cm | 10cm, 12cm, 15cm, 20cm & | ||
| 25cm | - | 15cm | ||
| Filter / Mesh sizes | LGD 240 and LGD60: 2000 | |||
| micron mesh at inlet and | ||||
| 1000 micron mesh at outlet |
- collected adipose tissue
passes though both meshes | - | The Puregraft 850 Bag
contains two (2) filters that
are continuous within the
bag. The first filter is an 800
micron filter mesh and the
second filter is a 74 micron
filter mesh. | Filters: 100 micron and 300
micron
Resizer: 500 micron |
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Image /page/6/Picture/1 description: The image contains the word "Cellmyx" in a sans-serif font. To the left of the word is a cluster of three yellow hexagons. The hexagons are arranged in a way that they are partially overlapping.
7
Image /page/7/Picture/1 description: The image shows the logo for Cellmyx. The logo consists of three hexagons of varying shades of yellow-orange on the left, followed by the company name "Cellmyx" in a simple, sans-serif font. The text is black and the overall design is clean and modern.
8
VII. Summary of Non-Clinical Testing and Risk Analysis
The performance of the device is entirely controlled by the user and is not predetermined by the device itself. The instructions for use advise the user on the proper user of the device.
Nonclinical testing included:
- Biocompatibility testing: .
- o Cytotoxicity
- o Sensitization
- o Intracutaneous Reactivity
- o Acute Systemic Toxicity
- Pyrogen o
- . Sterilization validation
- . Packaging validation
- . Nucleated cell viability
VIII. Clinical Testing
Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits.
IX. Conclusion
Based on the comparison of intended use and technological characteristics, Cellmyx has demonstrated that the intelliFat Kits are substantially equivalent to the predicate device.