(309 days)
K 070354
No
The device description and performance studies focus on the physical characteristics and safety of the needles, with no mention of AI or ML capabilities.
Yes
The device is used for the transient delivery of anesthetics to provide regional anesthesia, which involves numbing a part of the body to alleviate pain or sensation during medical procedures, thus providing a therapeutic effect.
No
The device is described as an "anesthesia conduction needle" intended for the "transient delivery of anesthetics" or to "facilitate placement of an epidural catheter." Its purpose is to administer substances or facilitate a procedure, not to diagnose a condition.
No
The device description clearly outlines physical components (needle tube, hub, stylet, jacket) and describes a physical procedure (intral punction and election of local and the end anesthelics into the epidural space). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter." This is a direct medical intervention on a patient's body.
- Device Description: The device is described as needles used for "epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies." This is a procedural device used for administering medication or facilitating a procedure within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such testing on specimens.
The device is clearly intended for direct use on a patient for a medical procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Anesthesia conduction needles are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Product codes
BSP
Device Description
needles, including Epidural Needle for Single Use(AN-E), Spinal Needle for Single Use(AN-S), AN-SII), consist of needle tube, hub, stylet and jacket The product is mainly used for epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies.
The needles have been categorized as following in detail:
- AN-SI Spinal Needles (same to IMD's Quincke needle)
- AN-SII Spinal Needle (same to IMD's Pencil point needle)
- AN-E Epidural Needles (same to IMD's Tuchy needle)
These needles are provided as sterile, single use devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needle. This is a simple hypodernic regional allestilesia trays (Mis). Anoonball concession of the aresthesia onduction needle. The later needie to hake the intral punction and election of local and the end anesthelics into the epidural space for longer pain relief.
The Shanghai SA's anesthesia conduction needles – AN-SI, AN-SII, AN-SII, AN-E – are single use, sterile madical devices for like The Shanghal SA s anesulesia conductions. The cannula is stabilized during puncture with use of an Inner thanslent delively of ancollobo acting regioned its reached its analogical site for regional style. This stylet is within atter the ansociety (i.e., within minutes) by the professional ansether and the possible. The altestiesia. Then the arestheses our as opplied below the anesthesia conduction needle. The needle is Allondavely of dealer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
Performance testing was conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device:
ISO 9626:-1991/Amd. 1:2001(E) "Stainless steel needle tubing for the manufacture of medical devices. "
ISO 7864:1993(E) "Sterile hypodermic needles for single use."
ISO 7864:1999(E) Stellie hypodernio no any of any of the synnges, needles and certain other medical equipment – Part 1:General Requirements."
ISO 594-2:1998 "Conical fittings with 6% (Liter) taper for syringes, needles and certain other medical equipment- Pant 2: Lock fittings. "
Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use.
Biocompaibility testing based on the nature and duration of patient outlined in ISO 10993-12009 "Biological Biocompability testing based on the nature and testing within a risk management process" demonstrates that the materials used in the construction of the proposed needles are safe for their intended use.
Sterlization is equivalent to predicate device since the materials, packaging, and sterilization processed are the same.
Key Metrics
Not Found
Predicate Device(s)
K 070354
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
KIZOY75
DEC 2 1 2012
Premarket Notification Section 510(k) Submission Section 3 510K Summary
Section 3 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date of Submission:
Submitted by:
Shanghai SA Medical & Plastic Instruments Co., Ltd Shanghai SA Medical & Plostion & Plostic Development Zone, Minhang District, Shanghai, P.R.C Contact Person: Mr. Xianming Cao Tel: +86-21-54332290 Fax: +86-21-54332600 Email: caoxm@sa001.com
Contact:
Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd Guangzhou Osthunda models Building, No.982 Congyun Rd, Baiyun District, Guangzhou, P.R.C Tel: +86-20-37612981 Fax: +86-20-37612253 Email: Mike.gu@osmundacn.com
Device Name:
AN-SI spinal needle,AN-SII spinal needle,AN-E epidural needle Trade Names: Common Names: Anesthesia conduction needles
Classification Name: Anesthesia conduction needles
Regulation Number: 21 CFR 868.5150
Product Class: Class II
Product Code: BSP
Preparation Date of Summary: Now 30, 2011
Predicate Device: IMD's Tuohy needle; Quincke needle; Pencil Point needle (K 070354)
Device Description:
Device Description: needles, including Epidural Needle for Single Use(AN-E), Spinal Needle for Single Use(AN-S), 1
1
AN-SII), consist of needle tube, hub, stylet and jacket The product is mainly used for epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies.
The needles have been categorized as following in detail:
-
AN-SI Spinal Needles (same to IMD's Quincke needle)
-
AN-SII Spinal Needle (same to IMD's Pencil point needle)
-
AN-E Epidural Needles (same to IMD's Tuchy needle)
These needles are provided as sterile, single use devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needle. This is a simple hypodernic regional allestilesia trays (Mis). Anoonball concession of the aresthesia onduction needle. The later needie to hake the intral punction and election of local and the end anesthelics into the epidural space for longer pain relief.
The Shanghai SA's anesthesia conduction needles – AN-SI, AN-SII, AN-SII, AN-E – are single use, sterile madical devices for like The Shanghal SA s anesulesia conductions. The cannula is stabilized during puncture with use of an Inner
thanslent delively of ancollobo acting regioned its reached its analogical site for regional style. This stylet is within atter the ansociety (i.e., within minutes) by the professional ansether and the possible. The altestiesia. Then the arestheses our as opplied below the anesthesia conduction needle. The needle is Allondavely of dealer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended Use:
Intended USe:
Anesthesia conduction needles are intended for the transient delivery of anesthelics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Technology Characteristics:
Technology Characterisuics:
The Shanghai SA anesthesia conduction needles- AN-E,AN-SI,AN-SIAN CLAN,GLAN,SLL on onivalent I he Shangha SA anesthesia Conduction needies AN-Spart of Child Sh-Sl.AN-SI-AN-SIL-an-SIL-an-SIL-an-SI-an-SI-AN-SI-AN-SI-AN-SI-AN-SI-AN-SIpredicale devices dentilies above. The Sharghal of Childer.
in design physical dimensions, luer hub, metal and plastic materials, and packaging to the IMD anesthesia needle c under 510(K) number K070354
The Anesthesia Conduction Needles general design characteristics and functionality are similar in that they meet performance standards where applicable for:
Stainless Steel components: ISO 9626 Hub: ISO 594-1 and ISO 594-2 Hub to Needle Bond Strength: ISO 7864
All statements and representations set forth herein regarding or related to "substantially equivalential to the Endoral Frod equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Frodd in the and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration as requiring including and Cosmetic Act, as almented, and application against interest under, any other laws or regulations, including
2
2
Premarket Notification Section 510(k) Submission Section 3 510K Summary
patent laws (whether in the context of patent infringement or otherwise).
Nonclinical testing Conclusion:
Nonclinical testing Conclusion.
Performance testing was conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device:
substantally equivalent to the predicate down.
ISO 9626:-1991/Amd. 1:2001(E) "Stainless steel needle tubing for the manufacture of medical devices. "
ISO 7864:1993(E) "Sterile hypodermic needles for single use."
(SO 7864:1999(E) Stellie hypodernio no any of any of the synnges, needles and certain other medical equipment – Part 1:General Requirements."
1:General Requirements.
ISO 594-2:1998 "Conical fittings with 6% (Liter) taper for syringes, needles and certain other medical equipment- Pant 2: Lock fittings. "
Lock fittings. "
Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use.
Biocompaibility testing based on the nature and duration of patient outlined in ISO 10993-12009 "Biological Biocompability testing based on the nature and testing within a risk management process" demonstrates that the materials used in the construction of the proposed needles are safe for their intended use.
Sterlization is equivalent to predicate device since the materials, packaging, and sterilization processed are the same.
SE Conclusion:
SE Conclusion:
The companson between the predicate devices and the proposed devices . Anathering peoples can be The companson between the predicate Genes and the predicate devices. Anesthesia conduction needles can be
safe and effective, as well as substantially equivale prodicets Devi safe and effective, as well as substant to one predicate device IMD's Tuchy needle; Quincke needle; Pencil Point needte K 070354.
ಆ
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes across its body.
December 21, 2012
Shanghai SA Medical & Plastic Instruments Company, Limited C/O Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Company, Limited 7th Floor, Jingui Business Building, No. 982 Congyun Road Baiyun District, Guangzhou China 510420
Re: K120475
Trade/Device Name: Anesthesia Conduction Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: December 12, 2012 Received: December 12, 2012
Dear Mr. Gu:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4
Page 2 - Mr. Gu
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Anthony Lo Russo
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification Section 510(k) Submission Section 2 Indication for Use Statement Ref No.:
Section 2 Indication for Use Statement
510(k) Number: K120475
Device Name: Anesthesia conduction needles
Indications for Use:
Anesthesia conduction needles are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Prescription Use ___ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page_1_of_1
Neel JJ Ratel
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120475