(48 days)
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.
I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, ground truth, or an MRMC comparative effectiveness study.
The document consists of a 510(k) premarket notification letter from the FDA to Shippert Medical Technologies Corporation regarding their EXPANDACELL™ Instrument Wipe. It primarily addresses the device's regulatory classification and substantial equivalence to existing devices.
The key points from the provided text are:
- Device Name: EXPANDACELL™ Instrument Wipe
- Regulatory Classification: Class I
- Product Code: GEC (Manual surgical instrument for general use)
- Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
- Basis for Equivalence: The summary of safety and effectiveness information (page 4) states that the device is "identical to existing medical devices" (K920355, K791736, and others by Ultracell, SomedMerocel, and Smith and Nephew) and is "identical in intended use, materials, anatomic model... population, physical safety, biocompatibility and performance to the predicate device."
- Indication for Use: "The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure."
The document does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or detailed performance metrics. It relies on the claim of substantial equivalence to previously cleared devices rather than providing new performance study data.
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April 9, 2024
Shippert Medical Technologies Corporation Sarah Maxwell Lake Head of Regulatory Affairs 7002 South Revere Parkwav, Suite 60 Englewood, Colorado 80112
Re: K960621
Trade/Device Name: EXPANDACELL™ Instrument Wipe Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: GEC
Dear Sarah Maxwell Lake:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 1, 1996. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code GEC.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, yu-chieh.chiu@fda.hhs.gov.
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. 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
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Public Health Service
Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 1996
Ms. Sarah M. Lake Head of Requlatory Affairs Shippert Medical Technologies Corporation 7002 South Revere Parkway, Suite 60 Englewood, Colorado 80112
Re: K960621 EXPANDACELL™ Instrument Wipe Trade Name: Regulatory Class: I Product Code: GER Dated: February 12, 1996 Received: February 13, 1996
Dear Ms. Lake:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Ms. Sarah M. Lake
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Kimber C. Richter, M.D. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K960621|1r+
Page 1 of 1
5 10(k) Number (if known):
Device Name: Expandace11 Instrument Wipe
Indications For Use:
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.
28 FEB 20
1122
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Desland K96062-1
Prescription Use
(Per 21 CFR 801.109)
OR
510k) Num
Over-The-Counter Use
(Optional Format 1-2-96)
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This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the written requirements of SMDA 1000 the submitted of Oro(K) safety and effectiveness information is being submitted
in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92
SAFETY AND EFFECTIVENESS OF EXPANDACELL™ INSTRUMENT WIPE
The Expandacell Instrument Wipe is identical to existing medical devices, K920355, K791736
and Nephamb and News andell instrument Wipes, marketed by Ultracell, SomedMerocel and Smith
and Nephew have a provent Wipes, marketed by Ultracel, SomedMerocel and Smith and News & Thise Instituten Wipes, marketed by Uitacelly Normally Rocel and Smith Stocel and Smiller and Smith Smith Smith Small And Smaller as safe and effective for use in surgery. There is no modification in the proposed device and the predicale offective
t is identical in intended use, materials, anatemic his model and go your is identical in intended use, materials, d device and the production
The proposed product is identical in intended use, materials, a levices, target the supplies product is lientical in intended use, materials, anat tax bites, target
population, physical safety, biocompatibility and performance to the predicate device sta
ty and performance to the predicate device stated
Sarah Maxwell Luke
Signature
February 12, 1996
Date
filename: 510kWIPE.doc
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.